Cardio Data
Country not established
- Devices
- 10
What Cardio Data makes
Cardio Data manufactures cardiac monitoring devices, including portable pacemaker recorders, Holter analysis systems, and ambulatory ECG recorders designed for long-term rhythm monitoring and diagnostic analysis.
The company’s products are classified as Class II medical devices under FDA regulations and are listed in the FDA’s 510(k) clearance registry. The portfolio is based in the United States.
Catalogue
Model SSR1 Holter Monitor Ref K873337
Regimes: 510(k) Registry: 510(k)Cardiodata Pace Recorder Ref K834257
Regimes: 510(k) Registry: 510(k)Holter Scanner Ref K881488
Regimes: 510(k) Registry: 510(k)Paceguard Ref K770264
Regimes: 510(k) Registry: 510(k)Cardio-Data System, #mark Iii Ref K812149
Regimes: 510(k) Registry: 510(k)Cardio Data MK4 Holter Analysis System Ref K850136
Regimes: 510(k) Registry: 510(k)Cardio Data Pacerecorder PR3 Ref K853262
Regimes: 510(k) Registry: 510(k)Prodigy And Prodigy Plus Ref K860167
Regimes: 510(k) Registry: 510(k)MK5 Detector & Alarm, Arrhythmia W/Software 2.11 Ref K900607
Regimes: 510(k) Registry: 510(k)Cardio Data Pacemaker Recorder Ref K831184
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Cardio Data have in the registry?
The registry currently lists 10 devices for Cardio Data. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cardio Data's devices?
Among its 10 most recently registered devices, Cardio Data has devices listed in FDA 510(k) (10 devices).
What risk classes do Cardio Data's devices fall under?
Among its 10 most recently registered devices, the classes recorded for Cardio Data's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Cardio Data in the registry?
The most recently registered devices listed for Cardio Data include MODEL SSR1 HOLTER MONITOR, CARDIODATA PACE RECORDER, HOLTER SCANNER and PACEGUARD.