The following data is part of a premarket notification filed by Respire Medical Holdings with the FDA for Respire Pink At (hard, Hard/soft, Ef).
| Device ID | K192127 |
| 510k Number | K192127 |
| Device Name: | Respire Pink AT (Hard, Hard/Soft, EF) |
| Classification | Device, Anti-snoring |
| Applicant | Respire Medical Holdings 18 Bridge St. Suite 3J Brooklyn, NY 11201 |
| Contact | Madubuike Okafor |
| Correspondent | Madubuike Okafor Respire Medical Holdings 18 Bridge St. Suite 3J Brooklyn, NY 11201 |
| Product Code | LRK |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-06 |
| Decision Date | 2020-02-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851861007277 | K192127 | 000 |
| 00851861007260 | K192127 | 000 |
| 00851861007253 | K192127 | 000 |