Sun Air, Inc.
JapanFDA applicant, unverified
- Devices
- 1
What Sun Air, Inc. makes
Sun Air, Inc. manufactures multiple Class I medical devices, including respiratory therapy equipment and related accessories designed for patient use in clinical and homecare settings.
These devices are regulated under the FDA’s 510(k) pathway as Class I products and are listed in the U.S. Food and Drug Administration’s database. The company is based in the United States.
Catalogue
Multiple Ref K853297
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Sun Air, Inc. have in the registry?
The registry currently lists 1 device for Sun Air, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sun Air, Inc.'s devices?
Among its 1 most recently registered device, Sun Air, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Sun Air, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Sun Air, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Sun Air, Inc. in the registry?
The most recently registered devices listed for Sun Air, Inc. include MULTIPLE.