Cpm International, Inc.
Country not established
- Devices
- 1
What Cpm International, Inc. makes
Cpm International, Inc. manufactures the DURAPULSE, a medical device designed for cardiac defibrillation and pacing applications, used in implantable cardioverter-defibrillators (ICDs) and pacemakers.
The DURAPULSE is classified as a Class III device under FDA regulations and requires a 510(k) clearance for market authorisation. The company is based in the United States.
Catalogue
Durapulse Ref K823371
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Cpm International, Inc. have in the registry?
The registry currently lists 1 device for Cpm International, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cpm International, Inc.'s devices?
Among its 1 most recently registered device, Cpm International, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Cpm International, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Cpm International, Inc.'s devices are Class III. Each device page shows its own class and authorisation.
What are the newest devices from Cpm International, Inc. in the registry?
The most recently registered devices listed for Cpm International, Inc. include DURAPULSE.