Sibel, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 3
What Sibel, Inc. makes
Sibel, Inc. manufactures continuous positive airway pressure (CPAP) devices, including the ANNE One, ANNE Pediatric, and ANNE Sleep models, designed for treating obstructive sleep apnea in adults and children.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. Sibel, Inc. is based in the United States.
Catalogue
ANNE One Ref K211305
510(k) 510(k)ANNE Pediatric Ref K221530
510(k) 510(k)ANNE Sleep Ref K220095
510(k) 510(k)
Frequently asked questions
How many devices does Sibel, Inc. have in the registry?
The registry currently lists 3 devices for Sibel, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sibel, Inc.'s devices?
Among its 3 most recently registered devices, Sibel, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Sibel, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Sibel, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Sibel, Inc. in the registry?
The most recently registered devices listed for Sibel, Inc. include ANNE One, ANNE Pediatric and ANNE Sleep.