The following data is part of a premarket notification filed by Respire Medical with the FDA for Respire Pink Series - Herbst.
| Device ID | K131138 |
| 510k Number | K131138 |
| Device Name: | RESPIRE PINK SERIES - HERBST |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-23 |
| Decision Date | 2013-09-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851861007147 | K131138 | 000 |
| 00851861007130 | K131138 | 000 |
| 00851861007086 | K131138 | 000 |
| 00851861007079 | K131138 | 000 |
| 00851861007048 | K131138 | 000 |
| 00851861007031 | K131138 | 000 |