Device product
Respire Pink H/S Oral Sleep Apnea Device
Z-1951-2018
Product summary
- Firm
- Respire Medical
- Event
- Event 80030
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-1951-2018
Official wording
Reason: Potential for device breakage during use
Code information: Serial Number: 50317
Distribution pattern: US nationwide distribution.
Derived failure modes
-
Unknown
Potential for device breakage during use