The following data is part of a premarket notification filed by Sleeping Well,llc with the FDA for Zquiet.
| Device ID | K180124 |
| 510k Number | K180124 |
| Device Name: | ZQuiet |
| Classification | Device, Anti-snoring |
| Applicant | Sleeping Well,LLC 5247 Shelburne Rd, Ste 204 Shelburne, VT 05482 |
| Contact | Daniel Webster |
| Correspondent | William G Mclain Keystone Regulatory Services, LLC 342 E. Main Street, Suite 207 Leola, PA 17540 |
| Product Code | LRK |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-16 |
| Decision Date | 2018-06-12 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ZQUIET 77575604 3681265 Live/Registered |
Sleeping Well, LLC 2008-09-22 |
![]() ZQUIET 77575598 3677702 Live/Registered |
Sleeping Well, LLC 2008-09-22 |