The following data is part of a premarket notification filed by Respire Medical Holding with the FDA for Respire Blue Series-ef.
| Device ID | K152292 |
| 510k Number | K152292 |
| Device Name: | Respire Blue Series-EF |
| Classification | Device, Anti-snoring |
| Applicant | Respire Medical Holding 18 Bridge Street Suite 4J Brooklyn, NY 11201 |
| Contact | David Walton |
| Correspondent | Stephen W Inglese Quality Solutions And Support, LLC PO BOX 8271 Holland, MI 49422 |
| Product Code | LRK |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-13 |
| Decision Date | 2015-12-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851861007123 | K152292 | 000 |
| 00851861007116 | K152292 | 000 |
| 00851861007024 | K152292 | 000 |