Optical Sensors, Inc.
United StatesFDA applicant, unverified
- Devices
- 7
What Optical Sensors, Inc. makes
Optical Sensors, Inc. manufactures point-of-care blood gas monitoring systems, including standalone devices and integrated probes such as the CapnoProbe SL and SensiCath. Their portfolio also includes arterial blood gas monitoring systems and related consumables, like the SensiLase Pad 3000, designed for real-time patient care in critical care settings. The company produces capnography probes and monitoring systems under the Olympus Critical Care brand.
These devices are classified as Class II under FDA regulations and are supported by 510(k) clearances. The portfolio is listed in the FDA’s 510(k) database. The company is based in the United States.
Catalogue
Point-Of-Care Blood Gas Monitor System Ref K961790
Regimes: 510(k) Registry: 510(k)Capno Probe A Ref K984579
Regimes: 510(k) Registry: 510(k)Capnoprobe Sl, Model 2000 Ref K010795
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Olympus Critical Care Monitoring System Ref K963935
Regimes: 510(k) Registry: 510(k)Sensilase Pad 3000 Ref K040654
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Optical Sensors, Inc. have in the registry?
The registry currently lists 7 devices for Optical Sensors, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Optical Sensors, Inc.'s devices?
Among its 7 most recently registered devices, Optical Sensors, Inc. has devices listed in FDA 510(k) (7 devices).
What risk classes do Optical Sensors, Inc.'s devices fall under?
Among its 7 most recently registered devices, the classes recorded for Optical Sensors, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Optical Sensors, Inc. in the registry?
The most recently registered devices listed for Optical Sensors, Inc. include POINT-OF-CARE BLOOD GAS MONITOR SYSTEM, CAPNO PROBE A, CAPNOPROBE SL, MODEL 2000 and SENSICATH POINT-OF-CARE BLOOD GAS MONITORING SYSTE.