Cardia Concepts Corp.
United StatesFDA applicant, unverified
- Devices
- 3
What Cardia Concepts Corp. makes
Cardia Concepts Corp. manufactures automated external defibrillators (AEDs) designed for emergency cardiac resuscitation, including the CPR Traveler, SAVE MOR, and CPR Helper. These devices are intended for use by trained responders to deliver electrical shocks and assist with chest compressions during cardiac arrest events.
The company’s products are classified as Class II medical devices under FDA regulations and are listed via the 510(k) pathway. The portfolio is registered in the FDA’s 510(k) database, and the manufacturer is based in the United States.
Catalogue
Cpr Traveler Ref K801947
Regimes: 510(k) Registry: 510(k)Save Mor Ref K801945
Regimes: 510(k) Registry: 510(k)Cpr Helper Ref K801946
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Cardia Concepts Corp. have in the registry?
The registry currently lists 3 devices for Cardia Concepts Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cardia Concepts Corp.'s devices?
Among its 3 most recently registered devices, Cardia Concepts Corp. has devices listed in FDA 510(k) (3 devices).
What risk classes do Cardia Concepts Corp.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Cardia Concepts Corp.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Cardia Concepts Corp. in the registry?
The most recently registered devices listed for Cardia Concepts Corp. include CPR TRAVELER, SAVE MOR and CPR HELPER.