Respcare, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Respcare, Inc. makes
Respcare, Inc. manufactures respiratory masks, including the UTOPIA system and variants such as the RESPCARE Face Mask and RESPCARE Hybrid AV Mask, designed for non-invasive ventilation and airway management.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Utopia Ref K052249
Regimes: 510(k) Registry: 510(k)Respcare Face Mask Ref K052227
Regimes: 510(k) Registry: 510(k)Respcare Hybrid Av Mask Ref K062224
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Respcare, Inc. have in the registry?
The registry currently lists 3 devices for Respcare, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Respcare, Inc.'s devices?
Among its 3 most recently registered devices, Respcare, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Respcare, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Respcare, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Respcare, Inc. in the registry?
The most recently registered devices listed for Respcare, Inc. include UTOPIA, RESPCARE FACE MASK and RESPCARE HYBRID AV MASK.