Mellenair Ent., Inc.
Country not established
- Devices
- 1
What Mellenair Ent., Inc. makes
Mellenair Ent., Inc. manufactures the REM-AIR, a respiratory device designed for use in medical settings to assist patients with breathing support.
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
Rem-Air Ref K924686
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Mellenair Ent., Inc. have in the registry?
The registry currently lists 1 device for Mellenair Ent., Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Mellenair Ent., Inc.'s devices?
Among its 1 most recently registered device, Mellenair Ent., Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Mellenair Ent., Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Mellenair Ent., Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Mellenair Ent., Inc. in the registry?
The most recently registered devices listed for Mellenair Ent., Inc. include REM-AIR.