Core-M, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Core-M, Inc. makes
Core-M, Inc. manufactures respiratory monitoring devices, including breath trackers such as the Breath Tracker™ Model 1800 Can-O-Gauge, as well as continuous monitoring systems like the Omicron Monitor and Delta Monitor. These products are designed for real-time assessment of respiratory patterns and airflow metrics in clinical or home settings.
The company’s portfolio is classified under FDA Class II devices and is supported by 510(k) clearances. These devices are listed in the FDA’s regulatory database, and the manufacturer is based in the United States.
Catalogue
Breath Tracker Ref K892942
Regimes: 510(k) Registry: 510(k)Breath Tracker(Tm) Model 1800 Can-O-Gauge Ref K921978
Regimes: 510(k) Registry: 510(k)Omicron Monitor, Delta Monitor Ref K960861
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Core-M, Inc. have in the registry?
The registry currently lists 3 devices for Core-M, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Core-M, Inc.'s devices?
Among its 3 most recently registered devices, Core-M, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Core-M, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Core-M, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Core-M, Inc. in the registry?
The most recently registered devices listed for Core-M, Inc. include BREATH TRACKER, BREATH TRACKER(TM) MODEL 1800 CAN-O-GAUGE and OMICRON MONITOR, DELTA MONITOR.