The following data is part of a premarket notification filed by Sleeping Well, Llc with the FDA for Zquiet Advance.
|Device Name:||ZQuiet Advance|
|Applicant||Sleeping Well, LLC 138 Steeplebush Rd. Shelburne, VT 05482|
Keystone Regulatory Services, LLC 342 E. Main Street, Suite 207 Leola, PA 17540
|CFR Regulation Number||872.5570 [🔎]|
|Decision||Substantially Equivalent (SESE)|
|3rd Party Reviewed||No|