PowerCube+ Series (PowerCube Body+); PowerCube+ Series (PowerCube Diffusion+); PowerCube+ Series (PowerCube Body+ / Diffusion+)
Ganshorn Medizin Electronic GmbH
GANSHORN MEDIZIN ELECTRONIC GMBH
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3006419626 | 3006419626 | GANSHORN MEDIZIN ELECTRONIC GMBH | 1 | N | 2026-01-01 | Theodor-Jopp-Str. 2 Bad Neustadt Bavaria DE 97616 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 204464 | 1699545686 | K240706 | PowerCube+ Series (PowerCube Body+); PowerCube+ Series (PowerCube Diffusion+); PowerCube+ Series (PowerCube Body+ / Diffusion+) | JEH | 2024-12-09 |
| 204464 | 1377794928 | K160116 | SpiroScout | BZG | 2016-10-07 |
| 204464 | 1170764465 |
Product Codes Associated With Registrations#
PMN#
SpiroScout
GANSHORN MEDIZIN ELECTRONIC GMBH
GUDID#
PowerCube+ Series - The PowerCube Body+ and Diffusion+ include a wheelchair-accessible body plethysmography chamber.
2024-12-20
PowerCube+ Series - The PowerCube Body+ include a standard Body Plethmography chamber with a door that opens to the right and bench seating.
2025-03-31
PowerCube+ Series - The PowerCube Body+ / Diffusion+ include a standard body plethysmography chamber with a door that opens to the right and bench seating.
2025-03-31
PowerCube+ Series - The PowerCube Body+ include a wheelchair body plethysmography chamber with a door that opens to the right.
2025-03-31
PowerCube+ Series - The PowerCube Body+ and Diffusion+ include a wheelchair-accessible body plethysmography chamber.
2025-03-31
PowerCube+ Series - The PowerCube Body+ include an extra-large body plethysmography chamber.
2025-03-31
PowerCube+ Series - The PowerCube Body+ and Diffusion+ include an extra-large body plethysmography chamber.
2025-03-31
PowerCube+ Series - The PowerCube Diffusion+ is equipped with the MultiX Trolley.
2025-03-31
PowerCube+ Series - The PowerCube Diffusion+ is equipped with the MultiX Trolley.
2024-12-20
PowerCube+ Series - The PowerCube Body+ and Diffusion+ include an extra-large body plethysmography chamber.
2024-12-20
PowerCube+ Series - The PowerCube Body+ include a standard Body Plethmography chamber with a door that opens to the left and bench seating.
2024-12-20
PowerCube+ Series - The PowerCube Body+ include a standard body plethysmography chamber with a door that opens to the left and chair seating.
2024-12-20
PowerCube+ Series - The PowerCube Body+ / Diffusion+ include a standard body plethysmography chamber with a door that opens to the left and bench seating.
2024-12-20
PowerCube+ Series - The PowerCube Body+ / Diffusion+ include a standard body plethysmography chamber with a door that opens to the left and chair seating.
2024-12-20
SpiroDef - SpiroDef Mouthpiece
2024-12-20
SpiroDef - SpiroDef ScoutTube
2024-12-20
SpiroDef - SpiroDef (Mouthpiece) with NoseClip
2024-12-20
SpiroDef - SpiroDef Mouthpiece
2024-12-20
SpiroDef - SpiroDef ScoutTube
2024-12-20
SpiroDef - SpiroDef (Mouthpiece) with NoseClip
2024-12-20
SpiroScout - The SpiroScout is a PC based system designed to measure and record FVC and SV Spiro recordings for adult and paediatric patients. Measurements are made with the SpiroScout ultrasound sensor. The SpiroScout sensor is supplied with either a disposable single- use ScoutTube, or a disposable single- use PFT Bacterial filter mouthpiece assembly. A ScoutTube or PFT filter is used for every patient to help prevent patient cross contamination. The SpiroScout is available with the following Options. Tidal Breath Analysis for paediatrics Rhinomanometrie Capnovolumetry (evaluation off additional parameters during tidal breathing, see software Ganshorn.LFX) HL7/ network (network connection via software Ganshorn.LFX)
2023-07-03
SpiroScout SP Plus - The SpiroScout SP plus is intended exclusively for use with the following SCHILLER devices. CARDIOVIT CS-104 SPIROVIT SP-1 G2 CARDIOVIT AT-102 G2The SpiroScout SP plus is an ultrasonic measuring system which is used for pulmonary function diagnostics. It determines the transit times of the ultrasonic signals and can be used with the above-mentioned Schiller devices to measure and analyse respiratory flow and volume.
2023-07-03
SpiroScout SP - The SpiroScout SP is a PC based system designed to measure and record FVC and SV Spiro recordings for adult and paediatric patients.Measurements are made with the SpiroScout ultrasound sensor. The SpiroScout sensor is supplied with either a disposable single- use ScoutTube, or a disposable single- use PFT Bacterial filter mouthpiece assembly. A ScoutTube or PFT filter is used for every patient to help prevent patient cross contamination.Spiroscout SP is technically identical to Spiroscout and is intended exclusively for use with Schiller's AT 102
2023-07-03
Noseclip - The Noseclip is designed to close the patient's nose during a lung function measurement.
2023-07-03
ScoutTube - The ScoutTube is a disposable breathing tube for lung function measurement in measuring systems with ultrasound sensor.The ScoutTube is intended for use with the spirometers SpiroScout, SpiroScout SP and SpiroScout SP plus.Operating mode / Physical Principle:The ScoutTube is a disposable breathing tube for lung function measurement in measuring systems with ultrasound sensor, namely spirometers SpiroScout, SpiroScout SP and SpiroScout SP plus. The ScoutTube bundles and directs the air exhaled by the patient past the ultrasound sensor of the spirometer. The values determined in the process are sent to a software-supported diagnostic system for evaluation. A diagnosis can then be made by the specialist staff on the basis of the measurement results.
2021-11-30
SpiroScout SP plus - The SpiroScout SP plus is intended exclusively for use with the following SCHILLER devices. CARDIOVIT CS-104 SPIROVIT SP-1 G2 CARDIOVIT AT-102 G2The SpiroScout SP plus is an ultrasonic measuring system which is used for pulmonary function diagnostics. It determines the transit times of the ultrasonic signals and can be used with the above-mentioned Schiller devices to measure and analyse respiratory flow and volume.
2021-12-20
SpiroScout SP - The SpiroScout SP is a PC based system designed to measure and record FVC and SV Spiro recordings for adult and paediatric patients.Measurements are made with the SpiroScout ultrasound sensor. The SpiroScout sensor is supplied with either a disposable single- use ScoutTube, or a disposable single- use PFT Bacterial filter mouthpiece assembly. A ScoutTube or PFT filter is used for every patient to help prevent patient cross contamination.Spiroscout SP is technically identical to Spiroscout and is intended exclusively for use with Schiller's AT 102
2021-11-30
SpiroScout - The SpiroScout is a PC based system designed to measure and record FVC and SV Spiro recordings for adult and paediatric patients. Measurements are made with the SpiroScout ultrasound sensor. The SpiroScout sensor is supplied with either a disposable single- use ScoutTube, or a disposable single- use PFT Bacterial filter mouthpiece assembly. A ScoutTube or PFT filter is used for every patient to help prevent patient cross contamination. The SpiroScout is available with the following Options. Tidal Breath Analysis for paediatrics Rhinomanometrie Capnovolumetry (evaluation off additional parameters during tidal breathing, see software Ganshorn.LFX) HL7/ network (network connection via software Ganshorn.LFX)
2017-02-07