510(k) K192127
K192127 is an FDA 510(k) premarket notification submitted by Respire Medical Holdings for the device "Respire Pink AT (Hard, Hard/Soft, EF)". The FDA issued a decision of Substantially Equivalent on Feb 5, 2020. The device falls under product code LRK (Device, Anti-Snoring), a Class II device regulated under 21 CFR 872.5570.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 5, 2020
- Date Received
- Aug 6, 2019
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Anti-Snoring
- Device Class
- Class II
- Regulation Number
- 872.5570
- Review Panel
- DE
- Submission Type
- 510(k)