Biotronik Cardiac Pacemakers
Country not established
- Devices
- 3
What Biotronik Cardiac Pacemakers makes
Biotronik Cardiac Pacemakers designs and manufactures implantable pulse generators, including the NEOS 02, NANOS, and KALOS 05, which are used for cardiac rhythm management to regulate heartbeats in patients with bradycardia or other arrhythmias.
These devices are classified as Class III under FDA regulations and are authorised via the 510(k) pathway. The company’s products are listed in the FDA’s 510(k) registry, and the manufacturer is based in the United States.
Catalogue
Neos 02 Ref K894240
Regimes: 510(k) Registry: 510(k)Nanos Ref K894239
Regimes: 510(k) Registry: 510(k)Kalos 05 Pulse Generator Ref K896184
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Biotronik Cardiac Pacemakers have in the registry?
The registry currently lists 3 devices for Biotronik Cardiac Pacemakers. Devices recorded under merged duplicate company entries are counted once.
Which registries list Biotronik Cardiac Pacemakers's devices?
Among its 3 most recently registered devices, Biotronik Cardiac Pacemakers has devices listed in FDA 510(k) (3 devices).
What risk classes do Biotronik Cardiac Pacemakers's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Biotronik Cardiac Pacemakers's devices are Class III. Each device page shows its own class and authorisation.
What are the newest devices from Biotronik Cardiac Pacemakers in the registry?
The most recently registered devices listed for Biotronik Cardiac Pacemakers include NEOS 02, NANOS and KALOS 05 PULSE GENERATOR.