Cardiosense, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Cardiosense, Inc. makes
Cardiosense, Inc. develops software for pulmonary capillary wedge pressure (PCWP) analysis and a wearable cardiac monitoring device called CardioTag™, designed for continuous hemodynamic and rhythm assessment.
The company’s portfolio includes Class II devices, authorised via FDA 510(k) clearance, and is based in the United States.
Catalogue
PCWP Analysis Software Ref DEN250057
Regimes: De Novo Registry: De NovoCardioTag™ Ref K243566
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Cardiosense, Inc. have in the registry?
The registry currently lists 2 devices for Cardiosense, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cardiosense, Inc.'s devices?
Among its 2 most recently registered devices, Cardiosense, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Cardiosense, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Cardiosense, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Cardiosense, Inc. in the registry?
The most recently registered devices listed for Cardiosense, Inc. include PCWP Analysis Software and CardioTag™.