The following data is part of a premarket notification filed by Sleeping Well, Llc with the FDA for Zquiet Pro-plus.
| Device ID | K122475 |
| 510k Number | K122475 |
| Device Name: | ZQUIET PRO-PLUS |
| Classification | Device, Anti-snoring |
| Applicant | SLEEPING WELL, LLC 5247 Shelburne Rd Ste 204 Shelburne, VT 05482 |
| Contact | Daniel Webster |
| Correspondent | Daniel Webster SLEEPING WELL, LLC 5247 Shelburne Rd Ste 204 Shelburne, VT 05482 |
| Product Code | LRK |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-14 |
| Decision Date | 2012-12-07 |
| Summary: | summary |