Corazonix Corp.
United StatesFDA applicant, unverified
- Devices
- 2
What Corazonix Corp. makes
Corazonix Corp. manufactures signal-averaging electrocardiogram (ECG) devices, including the PREDICTOR II and PREDICTOR models, designed for cardiac rhythm analysis and diagnostic evaluation.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) clearance pathway. The company is based in the United States.
Catalogue
Predictor Ii Signal Averaging Ecg Ref K883855
Regimes: 510(k) Registry: 510(k)Predictor Ref K871436
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Corazonix Corp. have in the registry?
The registry currently lists 2 devices for Corazonix Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Corazonix Corp.'s devices?
Among its 2 most recently registered devices, Corazonix Corp. has devices listed in FDA 510(k) (2 devices).
What risk classes do Corazonix Corp.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Corazonix Corp.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Corazonix Corp. in the registry?
The most recently registered devices listed for Corazonix Corp. include PREDICTOR II SIGNAL AVERAGING ECG and PREDICTOR.