ZQuiet Advance
K-Number: K213088 · 2022-06-15
ApplicantSleeping Well, LLC
Decision Date2022-06-15
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
ZQuiet Advance is a medical device manufactured by Sleeping Well, LLC. It received FDA 510(k) clearance on 2022-06-15 under approval number K213088. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ZQuiet Advance?
ZQuiet Advance is a medical device that received FDA 510(k) clearance on 2022-06-15. It is manufactured by Sleeping Well, LLC. The 510(k) number is K213088.
When was ZQuiet Advance approved by the FDA?
ZQuiet Advance received FDA 510(k) clearance on 2022-06-15, under approval number K213088.
What company makes ZQuiet Advance?
ZQuiet Advance is manufactured by Sleeping Well, LLC.
What is the FDA product code for ZQuiet Advance?
The FDA product code for ZQuiet Advance is LRK.
Other Devices by Sleeping Well, LLC
Related Devices (Code: LRK)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.