Cardio Kinetics, Inc.
United StatesFDA applicant, unverified
- Devices
- 5
What Cardio Kinetics, Inc. makes
Cardio Kinetics, Inc. manufactures cardiokymographic devices, including the CKG 8000, CKG Cardiokymograph, CKG 8800, and Series 602 CKG Recorders (both standard and modified versions). These devices are designed for measuring and recording cardiac wall motion and function, aiding in the assessment of myocardial performance.
The company’s products fall under FDA Class I and Class II device classifications, with regulatory clearance obtained through 510(k) submissions. The portfolio is listed in the FDA’s 510(k) database, and the manufacturer is based in the United States.
Catalogue
Ckg 8000 Ref K822020
Regimes: 510(k) Registry: 510(k)Ckg Cardiokymograph Ref K792051
Regimes: 510(k) Registry: 510(k)Ckg 8800 Ref K823215
Regimes: 510(k) Registry: 510(k)Series 602 Ckg Recorder (Modified) Ref K801485
Regimes: 510(k) Registry: 510(k)Series 602 Ckgtm Recorder Ref K800851
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Cardio Kinetics, Inc. have in the registry?
The registry currently lists 5 devices for Cardio Kinetics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cardio Kinetics, Inc.'s devices?
Among its 5 most recently registered devices, Cardio Kinetics, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Cardio Kinetics, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Cardio Kinetics, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Cardio Kinetics, Inc. in the registry?
The most recently registered devices listed for Cardio Kinetics, Inc. include CKG 8000, CKG CARDIOKYMOGRAPH, CKG 8800 and SERIES 602 CKG RECORDER (MODIFIED).