Fenem, Inc.
United StatesFDA applicant, unverified
- Devices
- 5
What Fenem, Inc. makes
Fenem, Inc. manufactures end-tidal carbon dioxide detectors and analyzers, including the FEF™ End-Tidal CO₂ Detector and the TOOB-CHEQ Carbon Dioxide Gas Analyzer. These devices are designed to monitor exhaled carbon dioxide levels, supporting respiratory assessment and patient safety in clinical settings.
The company’s portfolio consists of Class II medical devices, all of which are listed under the FDA’s 510(k) pathway. These devices are regulated under U.S. jurisdiction and comply with applicable U.S. medical device regulations.
Catalogue
Fef(Tm) End-Tidal CO2 Detector Ref K883821
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Modified Toob-Cheq Carbon Dioxide Gas Analyzer Ref K883950
Regimes: 510(k) Registry: 510(k)Modified Fef(Tm) End-Tidal CO2 Detector Ref K884080
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Fenem, Inc. have in the registry?
The registry currently lists 5 devices for Fenem, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Fenem, Inc.'s devices?
Among its 5 most recently registered devices, Fenem, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Fenem, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Fenem, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Fenem, Inc. in the registry?
The most recently registered devices listed for Fenem, Inc. include FEF(TM) END-TIDAL CO2 DETECTOR, 2ND MODIFICATION OF FEF(TM) END-TIDAL CO2 DETECTOR, MODIFIED CLAIMS FOR FEF(TM) END-TIDAL CO2 DETECTOR and MODIFIED TOOB-CHEQ CARBON DIOXIDE GAS ANALYZER.