Ceramatec, Inc.
United StatesFDA applicant, unverified
- Devices
- 4
What Ceramatec, Inc. makes
Ceramatec, Inc. manufactures galvanic oxygen sensors, including the MAXCELL and CAG models, as well as portable oxygen analyzers like the CERION Hand Held Oxygen Analyzer and the HANDI Oxygen Analyzer. These devices are designed for measuring and monitoring oxygen levels in various environments, including industrial and medical settings. The CERION Oxygen Threshold Alarm provides alerting functionality for oxygen concentration deviations.
The company’s products are classified as Class II medical devices under FDA regulations and are supported by 510(k) clearance records. These devices are listed in the FDA’s regulatory database, ensuring compliance with U.S. medical device standards. The company is headquartered in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Cerion Oxy Threshold Alarm Ref K880448
Regimes: 510(k) Registry: 510(k)Cerion Hand Held Oxygen Analyzer Ref K911344
Regimes: 510(k) Registry: 510(k)Handi Oxygen Analyzer Ref K973282
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Ceramatec, Inc. have in the registry?
The registry currently lists 4 devices for Ceramatec, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ceramatec, Inc.'s devices?
Among its 4 most recently registered devices, Ceramatec, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Ceramatec, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Ceramatec, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Ceramatec, Inc. in the registry?
The most recently registered devices listed for Ceramatec, Inc. include CERAMATEC MAXCELL AND CAG GALVANIC OXYGEN SENSORS, CERION OXY THRESHOLD ALARM, CERION HAND HELD OXYGEN ANALYZER and HANDI OXYGEN ANALYZER.