QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM; QMAPP GO; QMAPP EP
Fysicon BV
FYSICON BV
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3010716438 | 3010716438 | FYSICON BV | 1 | N | 2026-01-01 | Hoogheuvelstraat 114 Oss Noord-Brabant NL 5349BA |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 173658 | 1895095009 | K241766 | QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid) | MWI | 2025-08-27 |
| 173658 | 2063907652 | K170032 | QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM; QMAPP GO; QMAPP EP | MWI | 2017-09-08 |
| 173658 | 1360265795 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| MWI | 2 | 2025-08-27 |
PMN#
GUDID#
QMAPP - The QMAPP Hemo, a full-blown hemodynamic monitoring system, is designed to help make examinations even more efficient, by housing all parameters in one amplifier and making operation intuitive (reporting functionalities) in order to optimize the workflow. QMAPP Hemo is user-friendly and is connected with a single cable and mounted to a standard DIN-rail on the X-ray or operating table, which will increase the operational space and freedom of movement in the lab as shorter cables can be used. A QMAPP amplifier is hot swappable by disconnecting a single cable, without loss of patient or exam data.
2026-05-19
QMAPP - The QMAPP Hemo Lite, a basic hemodynamic monitoring system, is designed to help make examinations even more efficient, by housing all parameters in one amplifier and making operation intuitive (reporting functionalities) in order to optimize the workflow. QMAPP Hemo Lite is user-friendly and is connected with a single cable and mounted to a standard DIN-rail on the X-ray or operating table, which will increase the operational space and freedom of movement in the lab as shorter cables can be used. A QMAPP amplifier is hot swappable by disconnecting a single cable, without loss of patient or exam data.
2026-05-19
QMAPP - The QMAPP GO, a basic hemodynamic monitoring system on wheels, is designed to help make examinations even more efficient, by housing all parameters in one amplifier and making operation intuitive (reporting functionalities) in order to optimize the workflow. QMAPP GO contains all functionality’s you desire from a hemodynamic monitoring system placed on a trolley. This gives the user the ability to use these functions everywhere.
2026-05-19
QMAPP - The QMAPP PCM, a basic hemodynamic monitoring system, is designed to help make examinations even more efficient, by housing all parameters in one amplifier and making operation intuitive (reporting functionalities) in order to optimize the workflow. QMAPP PCM is user-friendly and is connected with a single cable and mounted to a standard DIN-rail on the X-ray or operating table, which will increase the operational space and freedom of movement in the lab as shorter cables can be used. A QMAPP amplifier is hot swappable by disconnecting a single cable, without loss of patient or procedure data.
2026-05-19
QMAPP - This ECG trunk cable or Lead Wire is intended to be used with ECG (EKG) monitoring devices such as a QMAPP hemodynamic monitoring systems. This ECG Trunk cable or Lead wire is used to connect electrodes to a monitoring device for general monitoring and/or diagnostic evaluation by a health care professional. This ECG Trunk cable or Lead wire are reusable.
2026-05-19
QMAPP - This ECG trunk cable or Lead Wire is intended to be used with ECG (EKG) monitoring devices such as a QMAPP hemodynamic monitoring systems. This ECG Trunk cable or Lead wire is used to connect electrodes to a monitoring device for general monitoring and/or diagnostic evaluation by a health care professional. This ECG Trunk cable or Lead wire are reusable.
2026-05-19
QMAPP - This ECG trunk cable or Lead Wire is intended to be used with ECG (EKG) monitoring devices such as a QMAPP hemodynamic monitoring systems. This ECG Trunk cable or Lead wire is used to connect electrodes to a monitoring device for general monitoring and/or diagnostic evaluation by a health care professional. This ECG Trunk cable or Lead wire are reusable.
2026-05-19
QMAPP - This ECG trunk cable or Lead Wire is intended to be used with ECG (EKG) monitoring devices such as a QMAPP hemodynamic monitoring systems. This ECG Trunk cable or Lead wire is used to connect electrodes to a monitoring device for general monitoring and/or diagnostic evaluation by a health care professional. This ECG Trunk cable or Lead wire are reusable.
2026-05-19
QMAPP - This ECG trunk cable or Lead Wire is intended to be used with ECG (EKG) monitoring devices such as a QMAPP hemodynamic monitoring systems. This ECG Trunk cable or Lead wire is used to connect electrodes to a monitoring device for general monitoring and/or diagnostic evaluation by a health care professional. This ECG Trunk cable or Lead wire are reusable.
2026-05-19
QMAPP - This ECG trunk cable or Lead Wire is intended to be used with ECG (EKG) monitoring devices such as a QMAPP hemodynamic monitoring systems. This ECG Trunk cable or Lead wire is used to connect electrodes to a monitoring device for general monitoring and/or diagnostic evaluation by a health care professional. This ECG Trunk cable or Lead wire are reusable.
2026-05-19
QMAPP - This Invasive Blood Pressure (IBP) connection cable is intended to be used with Invasive Blood Pressure monitoring devices. This IBP connection cable is used to connect a pressure transducer to a monitoring system for general monitoring and/or diagnostic evaluation by a health care professional. This IBP connection cable is reusable.
2026-05-19
QMAPP - This Invasive Blood Pressure (IBP) connection cable is intended to be used with Invasive Blood Pressure monitoring devices. This IBP connection cable is used to connect a pressure transducer to a monitoring system for general monitoring and/or diagnostic evaluation by a health care professional. This IBP connection cable is reusable.
2026-05-19
QMAPP - This Invasive Blood Pressure (IBP) connection cable is intended to be used with Invasive Blood Pressure monitoring devices. This IBP connection cable is used to connect a pressure transducer to a monitoring system for general monitoring and/or diagnostic evaluation by a health care professional. This IBP connection cable is reusable.
2026-05-19
QMAPP - This Invasive Blood Pressure (IBP) connection cable is intended to be used with Invasive Blood Pressure monitoring devices. This IBP connection cable is used to connect a pressure transducer to a monitoring system for general monitoring and/or diagnostic evaluation by a health care professional. This IBP connection cable is reusable.
2026-05-19
QMAPP - This Invasive Blood Pressure (IBP) connection cable is intended to be used with Invasive Blood Pressure monitoring devices. This IBP connection cable is used to connect a pressure transducer to a monitoring system for general monitoring and/or diagnostic evaluation by a health care professional. This IBP connection cable is reusable.
2026-05-19
QMAPP - This Invasive Blood Pressure (IBP) connection cable is intended to be used with Invasive Blood Pressure monitoring devices. This IBP connection cable is used to connect a pressure transducer to a monitoring system for general monitoring and/or diagnostic evaluation by a health care professional. This IBP connection cable is reusable.
2026-05-19
QMAPP - This Invasive Blood Pressure (IBP) connection cable is intended to be used with Invasive Blood Pressure monitoring devices. This IBP connection cable is used to connect a pressure transducer to a monitoring system for general monitoring and/or diagnostic evaluation by a health care professional. This IBP connection cable is reusable.
2026-05-19
QMAPP - This Invasive Blood Pressure (IBP) connection cable is intended to be used with Invasive Blood Pressure monitoring devices. This IBP connection cable is used to connect a pressure transducer to a monitoring system for general monitoring and/or diagnostic evaluation by a health care professional. This IBP connection cable is reusable.
2026-05-19
QMAPP - This Invasive Blood Pressure (IBP) connection cable is intended to be used with Invasive Blood Pressure monitoring devices. This IBP connection cable is used to connect a pressure transducer to a monitoring system for general monitoring and/or diagnostic evaluation by a health care professional. This IBP connection cable is reusable.
2026-05-19
QMAPP - This SpO2 connection cable is intended to be used when continuous non-invasive arterial oxygen saturation and pulse rate monitoring is required. SpO2 can be measured with SpO2 monitoring devices, such as a QMAPP hemodynamic monitoring system. The SpO2 connection cable is specifically intended to be used to connect a SpO2 sensor to the QMAPP amplifier by a health care professional.The sensor is contraindicated for use on active patients, conditions of motion or for prolonged use. This SpO2 connection cable is reusable, unless otherwise stated.
2026-05-19
QMAPP - The Reusable (durable) and Disposable Blood Pressure Cuffs are intended to be used with a non-invasive blood pressure measurement system, such as QMAPP, to determine blood pressure parameters on pediatric and adult patients. The Reusable (durable) and Disposable BP cuffs are a single bladder and shell construction, use to support ease of cleaning.
2026-05-19
QMAPP - The Reusable (durable) and Disposable Blood Pressure Cuffs are intended to be used with a non-invasive blood pressure measurement system, such as QMAPP, to determine blood pressure parameters on pediatric and adult patients. The Reusable (durable) and Disposable BP cuffs are a single bladder and shell construction, use to support ease of cleaning.
2026-05-19
QMAPP - The Reusable (durable) and Disposable Blood Pressure Cuffs are intended to be used with a non-invasive blood pressure measurement system, such as QMAPP, to determine blood pressure parameters on pediatric and adult patients. The Reusable (durable) and Disposable BP cuffs are a single bladder and shell construction, use to support ease of cleaning.
2026-05-19
QMAPP - The Reusable (durable) and Disposable Blood Pressure Cuffs are intended to be used with a non-invasive blood pressure measurement system, such as QMAPP, to determine blood pressure parameters on pediatric and adult patients. The Reusable (durable) and Disposable BP cuffs are a single bladder and shell construction, use to support ease of cleaning.
2026-05-19
QMAPP - The Reusable (durable) and Disposable Blood Pressure Cuffs are intended to be used with a non-invasive blood pressure measurement system, such as QMAPP, to determine blood pressure parameters on pediatric and adult patients. The Reusable (durable) and Disposable BP cuffs are a single bladder and shell construction, use to support ease of cleaning.
2026-05-19
QMAPP - The Reusable (durable) and Disposable Blood Pressure Cuffs are intended to be used with a non-invasive blood pressure measurement system, such as QMAPP, to determine blood pressure parameters on pediatric and adult patients. The Reusable (durable) and Disposable BP cuffs are a single bladder and shell construction, use to support ease of cleaning.
2026-05-19
QMAPP - The Reusable (durable) and Disposable Blood Pressure Cuffs are intended to be used with a non-invasive blood pressure measurement system, such as QMAPP, to determine blood pressure parameters on pediatric and adult patients. The Reusable (durable) and Disposable BP cuffs are a single bladder and shell construction, use to support ease of cleaning.
2026-05-19
QMAPP - The Reusable (durable) and Disposable Blood Pressure Cuffs are intended to be used with a non-invasive blood pressure measurement system, such as QMAPP, to determine blood pressure parameters on pediatric and adult patients. The Reusable (durable) and Disposable BP cuffs are a single bladder and shell construction, use to support ease of cleaning.
2026-05-19
QMAPP - The Reusable (durable) and Disposable Blood Pressure Cuffs are intended to be used with a non-invasive blood pressure measurement system, such as QMAPP, to determine blood pressure parameters on pediatric and adult patients. The Reusable (durable) and Disposable BP cuffs are a single bladder and shell construction, use to support ease of cleaning.
2026-05-19
QMAPP - The Reusable (durable) and Disposable Blood Pressure Cuffs are intended to be used with a non-invasive blood pressure measurement system, such as QMAPP, to determine blood pressure parameters on pediatric and adult patients. The Reusable (durable) and Disposable BP cuffs are a single bladder and shell construction, use to support ease of cleaning.
2026-05-19
QMAPP - The Reusable (durable) and Disposable Blood Pressure Cuffs are intended to be used with a non-invasive blood pressure measurement system, such as QMAPP, to determine blood pressure parameters on pediatric and adult patients. The Reusable (durable) and Disposable BP cuffs are a single bladder and shell construction, use to support ease of cleaning.
2026-05-19
QMAPP - The Reusable (durable) and Disposable Blood Pressure Cuffs are intended to be used with a non-invasive blood pressure measurement system, such as QMAPP, to determine blood pressure parameters on pediatric and adult patients. The Reusable (durable) and Disposable BP cuffs are a single bladder and shell construction, use to support ease of cleaning.
2026-05-19
QMAPP - The Reusable (durable) and Disposable Blood Pressure Cuffs are intended to be used with a non-invasive blood pressure measurement system, such as QMAPP, to determine blood pressure parameters on pediatric and adult patients. The Reusable (durable) and Disposable BP cuffs are a single bladder and shell construction, use to support ease of cleaning.
2026-05-19
QMAPP - This Blood Pressure Cuff is a non-invasive blood pressure cuff, intended for use in conjunction with non-automated and automated sphygmomanometers, such as QMAPP, to determine blood pressure in pediatric through adult patients. The QMAPP NiBP connection hose, is a hose that interconnects a reusable or disposable NiBP cuff to a QMAPP amplifier. This NiBP connection hose or cuff is reusable, unless otherwise stated.
2026-05-19
QMAPP - This Blood Pressure Cuff is a non-invasive blood pressure cuff, intended for use in conjunction with non-automated and automated sphygmomanometers, such as QMAPP, to determine blood pressure in pediatric through adult patients. The QMAPP NiBP connection hose, is a hose that interconnects a reusable or disposable NiBP cuff to a QMAPP amplifier. This NiBP connection hose or cuff is reusable, unless otherwise stated.
2026-05-19
QMAPP - This Thermodilution Cardiac Output cable is intended to be used when the Cardiac Output (in L/min) is being measured using a Swan Ganz catheter with (patient care) monitoring devices, such as QMAPP. This Thermodilution CO Y-cable connects the Swan Ganz catheter and a (reference) temperature probe to a QMAPP hemodynamic monitoring system. This thermodilution CO Y-cable is reusable.
2026-05-19
QMAPP - This FFR Connection cable is intended to be used to connect external FFR systems to a QMAPP hemodynamic monitoring system. This QMAPP FFR connection cable is reusable.
2026-05-19
QMAPP - This FFR Connection cable is intended to be used to connect external FFR systems to a QMAPP hemodynamic monitoring system. This QMAPP FFR connection cable is reusable.
2026-05-19
QMAPP - This FFR Connection cable is intended to be used to connect external FFR systems to a QMAPP hemodynamic monitoring system. This QMAPP FFR connection cable is reusable.
2026-05-19
QMAPP - This FFR Connection cable is intended to be used to connect external FFR systems to a QMAPP hemodynamic monitoring system. This QMAPP FFR connection cable is reusable.
2026-05-19