Biosensors International USA, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
Catalogue
- Regimes: 510(k) Registry: 510(k)
Accutrans Disposable Pressure Monitoring System Ref K070710
Regimes: 510(k) Registry: 510(k)BioFreedom Drug Coated Coronary Stent System Ref P190020
Regimes: PMA, withdrawn Registry: PMA
Frequently asked questions
How many devices does Biosensors International USA, Inc. have in the registry?
The registry currently lists 3 devices for Biosensors International USA, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Biosensors International USA, Inc.'s devices?
Among its 3 most recently registered devices, Biosensors International USA, Inc. has devices listed in FDA 510(k) (2 devices) and FDA PMA (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Biosensors International USA, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Biosensors International USA, Inc.'s devices are Class II and Class III. Each device page shows its own class and authorisation.
What are the newest devices from Biosensors International USA, Inc. in the registry?
The most recently registered devices listed for Biosensors International USA, Inc. include CARDIAC OUTPUT KIT, MODEL CO-1 & INLINE SENSOR CABLE, MODEL ILS-1, ACCUTRANS DISPOSABLE PRESSURE MONITORING SYSTEM and BioFreedom Drug Coated Coronary Stent System.