Bionica, Inc.
Country not established
- Devices
- 3
What Bionica, Inc. makes
Bionica, Inc. manufactures ambulatory and personal infusion pumps, including the Bionica MDS 110 Patient-Controlled Analgesia (PCA) pump, designed for controlled medication delivery in outpatient and home settings.
The company’s devices are classified as Class II under FDA regulations and are listed via the 510(k) clearance process. The manufacturer is based in the United States.
Catalogue
Ambulatory Infusion Pump Ref K895426
Regimes: 510(k) Registry: 510(k)Personal Infusion Pump Ref K864276
Regimes: 510(k) Registry: 510(k)Bionica Mds 110 Pca Ref K875316
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Bionica, Inc. have in the registry?
The registry currently lists 3 devices for Bionica, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bionica, Inc.'s devices?
Among its 3 most recently registered devices, Bionica, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Bionica, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Bionica, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Bionica, Inc. in the registry?
The most recently registered devices listed for Bionica, Inc. include AMBULATORY INFUSION PUMP, PERSONAL INFUSION PUMP and BIONICA MDS 110 PCA.