Cardiac Evaluation Center, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Cardiac Evaluation Center, Inc. makes
Cardiac Evaluation Center, Inc. manufactures ECG memory loop recorders, including standalone devices like the RETROSPECTIVE II-ELITE and modular attachments such as the RETROSPECTIVE ECG Memory Module. These products are designed to continuously record and store electrocardiogram data for later review, supporting diagnostic evaluation of cardiac events.
The company’s devices are classified under Class II in the US and are listed in the FDA’s 510(k) registry. The portfolio is regulated under US medical device laws, with no additional international listings referenced.
Catalogue
Retrospective Ii-Elite Ecg Memory Loop Recorder Ref K954163
Regimes: 510(k) Registry: 510(k)Restrospective Ecg Memory Module Ref K831406
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Cardiac Evaluation Center, Inc. have in the registry?
The registry currently lists 2 devices for Cardiac Evaluation Center, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cardiac Evaluation Center, Inc.'s devices?
Among its 2 most recently registered devices, Cardiac Evaluation Center, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Cardiac Evaluation Center, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Cardiac Evaluation Center, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Cardiac Evaluation Center, Inc. in the registry?
The most recently registered devices listed for Cardiac Evaluation Center, Inc. include RETROSPECTIVE II-ELITE ECG MEMORY LOOP RECORDER and RESTROSPECTIVE ECG MEMORY MODULE.