Airoflex Medical, Inc.
Country not established
- Devices
- 1
What Airoflex Medical, Inc. makes
Airoflex Medical, Inc. manufactures the Babyflex Patient Circuit, a device designed for neonatal and pediatric respiratory support, facilitating oxygen delivery and ventilation in infants and young children.
The Babyflex Patient Circuit is classified as a Class I medical device under FDA regulations and is listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Babyflex Patient Circuit Ref K874559
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Airoflex Medical, Inc. have in the registry?
The registry currently lists 1 device for Airoflex Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Airoflex Medical, Inc.'s devices?
Among its 1 most recently registered device, Airoflex Medical, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Airoflex Medical, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Airoflex Medical, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Airoflex Medical, Inc. in the registry?
The most recently registered devices listed for Airoflex Medical, Inc. include BABYFLEX PATIENT CIRCUIT.