CardioDay V2.5
GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG
GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3004006614 | 3004006614 | GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG | 1 | N | 2026-01-01 | ODERSTRASSE 77 TELTOW Brandenburg DE 14513 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 21073 | 1683831939 | K162023 | CardioDay V2.5 | DQK | 2017-03-24 |
| 21073 | 1495279677 | K130785 | SEER 1000 | MWJ | 2013-07-26 |
| 21073 | 1657556595 | K130516 | CARDIODAY | DQK | 2013-08-23 |
| 21073 | 1347237808 | K122272 | CARDIOMEM | MWJ | 2013-03-28 |
| 21073 | 1444163570 | K063042 | CARDIOMEM CM 3000-12BT | MWJ | 2007-05-30 |
| 21073 | 1963255127 | K051686 | CARDIOMEM CM 3000-12 | MWJ | 2005-07-14 |
| 21073 | 1906289967 | K022540 | CARDIO ID+(RZ153+) | DSH | 2002-10-24 |
Product Codes Associated With Registrations#
PMN#
CARDIODAY
GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG
SEER 1000
GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG
CARDIOMEM
GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG
CARDIOMEM CM 3000-12BT
GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG
CARDIODAY, VERSION 2.0
GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG
CARDIOMEM CM 3000-12
GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG
CARDIODAY
GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG
GUDID#
CardioMem - The CardioMem CM 4000 and CM 4000 B digital Holter recorders are intended to continuously record ECG data. The recorders per-form no cardiac analysis by themselves and are intended to be used with an ECG analysis software package. The recorded data are down-loaded to a PC for analysis and subsequent evaluation by a trained physician or health care professional.
2026-05-01
SEER 1000 - The SEER 1000 digital Holter recorder is intended to continuously record ECG data. The SEER 1000 performs no cardiac analysis by itself and is in-tended to be used with an ECG analysis software package. The recorded data are downloaded to a PC for analysis and subsequent evaluation by a trained physician or healthcare professional.
2021-06-17
SEER 1000 - The SEER 1000 digital Holter recorder is intended to continuously record ECG data. The SEER 1000 performs no cardiac analysis by itself and is in-tended to be used with an ECG analysis software package. The recorded data are downloaded to a PC for analysis and subsequent evaluation by a trained physician or healthcare professional.
2021-06-17
SEER 1000 - The SEER 1000 digital Holter recorder is intended to continuously record ECG data. The SEER 1000 performs no cardiac analysis by itself and is in-tended to be used with an ECG analysis software package. The recorded data are downloaded to a PC for analysis and subsequent evaluation by a trained physician or healthcare professional.
2021-06-17
SEER 1000 - The SEER 1000 digital Holter recorder is intended to continuously record ECG data. The SEER 1000 performs no cardiac analysis by itself and is in-tended to be used with an ECG analysis software package. The recorded data are downloaded to a PC for analysis and subsequent evaluation by a trained physician or healthcare professional.
2025-03-14
SEER 1000 - The SEER 1000 digital Holter recorder is intended to continuously record ECG data. The SEER 1000 performs no cardiac analysis by itself and is in-tended to be used with an ECG analysis software package. The recorded data are downloaded to a PC for analysis and subsequent evaluation by a trained physician or healthcare professional.
2025-03-14
SEER 1000 - The SEER 1000 digital Holter recorder is intended to continuously record ECG data. The SEER 1000 performs no cardiac analysis by itself and is in-tended to be used with an ECG analysis software package. The recorded data are downloaded to a PC for analysis and subsequent evaluation by a trained physician or healthcare professional.
2025-03-14
SEER 1000 - The SEER 1000 digital Holter recorder is intended to continuously record ECG data. The SEER 1000 performs no cardiac analysis by itself and is in-tended to be used with an ECG analysis software package. The recorded data are downloaded to a PC for analysis and subsequent evaluation by a trained physician or healthcare professional.
2025-03-04
SEER 1000 - The SEER 1000 digital Holter recorder is intended to continuously record ECG data. The SEER 1000 performs no cardiac analysis by itself and is in-tended to be used with an ECG analysis software package. The recorded data are downloaded to a PC for analysis and subsequent evaluation by a trained physician or healthcare professional.
2025-03-04
SEER 1000 - The SEER 1000 digital Holter recorder is intended to continuously record ECG data. The SEER 1000 performs no cardiac analysis by itself and is in-tended to be used with an ECG analysis software package. The recorded data are downloaded to a PC for analysis and subsequent evaluation by a trained physician or healthcare professional.
2025-03-04
SEER 1000 - The SEER 1000 digital Holter recorder is intended to continuously record ECG data. The SEER 1000 performs no cardiac analysis by itself and is in-tended to be used with an ECG analysis software package. The recorded data are downloaded to a PC for analysis and subsequent evaluation by a trained physician or healthcare professional.
2025-03-04
SEER 1000 - The SEER 1000 digital Holter recorder is intended to continuously record ECG data. The SEER 1000 performs no cardiac analysis by itself and is in-tended to be used with an ECG analysis software package. The recorded data are downloaded to a PC for analysis and subsequent evaluation by a trained physician or healthcare professional.
2025-03-04
SEER 1000 - The SEER 1000 digital Holter recorder is intended to continuously record ECG data. The SEER 1000 performs no cardiac analysis by itself and is in-tended to be used with an ECG analysis software package. The recorded data are downloaded to a PC for analysis and subsequent evaluation by a trained physician or healthcare professional.
2025-03-04
ECG Cable for SEER 1000 - The cable is intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine ( SEER 1000 recorder).
2019-09-12
ECG Cable for SEER 1000 - The cable is intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine ( SEER 1000 recorder).
2019-09-12
ECG Cable for SEER 1000 - The cable is intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine ( SEER 1000 recorder).
2019-09-12
ECG Cable for SEER 1000 - The cable is intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine ( SEER 1000 recorder).
2019-09-12
ECG Cable for SEER 1000 - The cable is intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine ( SEER 1000 recorder).
2019-09-12
ECG Cable for SEER 1000 - The cable is intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine ( SEER 1000 recorder).
2019-09-12
ECG Cable for SEER 1000 - The cable is intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine ( SEER 1000 recorder).
2019-09-12
ECG Cable for SEER 1000 - The cable is intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine ( SEER 1000 recorder).
2019-09-12
ECG Cable for SEER 1000 - The cable is intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine ( SEER 1000 recorder).
2019-09-12
ECG Cable for SEER 1000 - The cable is intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine ( SEER 1000 recorder).
2019-09-12
ECG Cable for SEER 1000 - The cable is intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine ( SEER 1000 recorder).
2019-09-12
ECG Cable for SEER 1000 - The cable is intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine ( SEER 1000 recorder).
2019-09-12
ECG Cable for CM 3000-12 BT / SEER 12 - The cable is intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine (CM 3000-12 BT, SEER 12 recorder).
2019-09-12
ECG Cable for CM 3000-12 BT / SEER 12 - The cable is intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine (CM 3000-12 BT, SEER 12 recorder).
2019-09-12
ECG Cable for CM 3000-12 BT / SEER 12 - The cable is intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine (CM 3000-12 BT, SEER 12 recorder).
2019-09-12
ECG Cable for CM 3000-12 BT / SEER 12 - The cable is intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine (CM 3000-12 BT, SEER 12 recorder).
2019-09-12
ECG Leadwire Set for CM 3000 Series - The cable is intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine (CM 3000 recorder).
2016-09-21
ECG Leadwire Set for CM 3000 Series - The cable is intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine (CM 3000 recorder).
2016-09-21
ECG Trunk Cable for CM 3000 Series - The cable is intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine (CM 3000 recorder).
2016-09-21
ECG Trunk Cable for CM 3000 Series - The cable is intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine (CM 3000 recorder).
2016-09-21
ECG Leadwire Set for CM 3000 Series - The cable is intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine (CM 3000 recorder).
2016-09-21
ECG Trunk Cable for CM 3000 Series - The cable is intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine (CM 3000 recorder).
2016-09-21
SEER 1000 ECG Cable - The cable is intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine ( SEER 1000 recorder).
2016-09-21
SEER 1000 ECG Cable - The cable is intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine ( SEER 1000 recorder).
2016-09-21
SEER 1000 ECG Cable - The cable is intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine ( SEER 1000 recorder).
2016-09-21
SEER 1000 ECG Cable - The cable is intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine ( SEER 1000 recorder).
2016-09-21
SEER 1000 ECG Cable - The cable is intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine ( SEER 1000 recorder).
2016-09-21