Device product
Respire Pink Series EF+ Oral Sleep Apnea Device.
Z-1947-2018
Product summary
- Firm
- Respire Medical
- Event
- Event 80030
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1 unit
- Official record key
device-enforcement:Z-1947-2018
Official wording
Reason: Potential for device breakage during use
Code information: Serial Number: 50837
Distribution pattern: US nationwide distribution.
Derived failure modes
-
Unknown
Potential for device breakage during use