Omega Medical Corp.
United StatesFDA applicant, unverified
- Devices
- 2
What Omega Medical Corp. makes
Omega Medical Corp. manufactures non-invasive temperature scanning devices, including tympanic and surface temperature scanners designed for clinical and point-of-care use.
The company’s products are classified as Class II devices under FDA regulations and are listed via the 510(k) pathway. The manufacturer is based in the United States.
Catalogue
Tympanic Temperature Scanner Ref K882949
Regimes: 510(k) Registry: 510(k)Surface Temperature Scanner Ref K873010
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Omega Medical Corp. have in the registry?
The registry currently lists 2 devices for Omega Medical Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Omega Medical Corp.'s devices?
Among its 2 most recently registered devices, Omega Medical Corp. has devices listed in FDA 510(k) (2 devices).
What risk classes do Omega Medical Corp.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Omega Medical Corp.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Omega Medical Corp. in the registry?
The most recently registered devices listed for Omega Medical Corp. include TYMPANIC TEMPERATURE SCANNER and SURFACE TEMPERATURE SCANNER.