The following data is part of a premarket notification filed by Respire Medical with the FDA for Respire Blue Series.
| Device ID | K111207 |
| 510k Number | K111207 |
| Device Name: | RESPIRE BLUE SERIES |
| Classification | Device, Anti-snoring |
| Applicant | RESPIRE MEDICAL 22817 VENTURA BLVD #161 Woodland Hills, CA 91364 |
| Contact | Daniela Levy |
| Correspondent | Daniela Levy RESPIRE MEDICAL 22817 VENTURA BLVD #161 Woodland Hills, CA 91364 |
| Product Code | LRK |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-29 |
| Decision Date | 2011-08-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851861007109 | K111207 | 000 |
| 00851861007093 | K111207 | 000 |
| 00851861007017 | K111207 | 000 |
| 00851861007000 | K111207 | 000 |