Biotronics Corp.
United StatesFDA applicant, unverified
- Devices
- 2
What Biotronics Corp. makes
Biotronics Corp. manufactures external cardiac pacemakers, including the ETP 180 model, designed for temporary pacing support. The BIOTRON 18 is also part of their portfolio, though its specific function is not detailed.
Their devices fall under FDA Class II regulation and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Biotron 18 Ref K771534
Regimes: 510(k) Registry: 510(k)Etp 180 Cardiac Pacemaker (External) Ref K860551
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Biotronics Corp. have in the registry?
The registry currently lists 2 devices for Biotronics Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Biotronics Corp.'s devices?
Among its 2 most recently registered devices, Biotronics Corp. has devices listed in FDA 510(k) (2 devices).
What risk classes do Biotronics Corp.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Biotronics Corp.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Biotronics Corp. in the registry?
The most recently registered devices listed for Biotronics Corp. include BIOTRON 18 and ETP 180 CARDIAC PACEMAKER (EXTERNAL).