510(k) K111207
K111207 is an FDA 510(k) premarket notification submitted by Respire Medical for the device "RESPIRE BLUE SERIES". The FDA issued a decision of Substantially Equivalent on August 23, 2011. The device falls under product code LRK (Device, Anti-Snoring), a Class II device regulated under 21 CFR 872.5570. Respire Medical has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 23, 2011
- Date Received
- April 29, 2011
- Clearance Type
- Abbreviated
- 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