Racal Health & Safety, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Racal Health & Safety, Inc. makes
Racal Health & Safety, Inc. manufactures respiratory support devices, including the BNOS Microvent (Models AC and AO) for neonatal ventilation, the Intego for continuous positive airway pressure (CPAP) therapy, and the Zephyr for noninvasive ventilation in pediatric and adult patients.
The company’s products are regulated under FDA’s Class I and Class II classifications, with relevant devices listed via the 510(k) pathway. The manufacturer is based in the United States.
Catalogue
Bnos Microvent, Model Ac And Model Ao Ref K944397
Regimes: 510(k) Registry: 510(k)Intego Ref K910904
Regimes: 510(k) Registry: 510(k)Zephyr Ref K880534
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Racal Health & Safety, Inc. have in the registry?
The registry currently lists 3 devices for Racal Health & Safety, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Racal Health & Safety, Inc.'s devices?
Among its 3 most recently registered devices, Racal Health & Safety, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Racal Health & Safety, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Racal Health & Safety, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Racal Health & Safety, Inc. in the registry?
The most recently registered devices listed for Racal Health & Safety, Inc. include BNOS MICROVENT, MODEL AC AND MODEL AO, INTEGO and ZEPHYR.