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 |