Berkeley Bio-Engineering
Country not established
- Devices
- 4
What Berkeley Bio-Engineering makes
Berkeley Bio-Engineering manufactures medical devices including a fetal heart monitor (Model 1980), a biotome, an endotome, and a fragmatome (Model 820). These devices are specialized surgical and monitoring instruments used in medical procedures.
The company's portfolio includes Class I and Class II devices, which are listed in the FDA 510(k) registry. Berkeley Bio-Engineering is based in the US.
Catalogue
Monitor, Fetal Heart, Model 1980 Ref K770292
Regimes: 510(k) Registry: 510(k)Biotome Ref K771711
Regimes: 510(k) Registry: 510(k)Endotome Ref K790645
Regimes: 510(k) Registry: 510(k)Fragmatome Model 820 Ref K771644
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Berkeley Bio-Engineering have in the registry?
The registry currently lists 4 devices for Berkeley Bio-Engineering. Devices recorded under merged duplicate company entries are counted once.
Which registries list Berkeley Bio-Engineering's devices?
Among its 4 most recently registered devices, Berkeley Bio-Engineering has devices listed in FDA 510(k) (4 devices).
What risk classes do Berkeley Bio-Engineering's devices fall under?
Among its 4 most recently registered devices, the classes recorded for Berkeley Bio-Engineering's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Berkeley Bio-Engineering in the registry?
The most recently registered devices listed for Berkeley Bio-Engineering include MONITOR, FETAL HEART, MODEL 1980, BIOTOME, ENDOTOME and FRAGMATOME MODEL 820.