ZQuiet
K-Number: K180124 · 2018-06-12
ApplicantSleeping Well, LLC
Decision Date2018-06-12
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
ZQuiet is a medical device manufactured by Sleeping Well, LLC. It received FDA 510(k) clearance on 2018-06-12 under approval number K180124. 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?
ZQuiet is a medical device that received FDA 510(k) clearance on 2018-06-12. It is manufactured by Sleeping Well, LLC. The 510(k) number is K180124.
When was ZQuiet approved by the FDA?
ZQuiet received FDA 510(k) clearance on 2018-06-12, under approval number K180124.
What company makes ZQuiet?
ZQuiet is manufactured by Sleeping Well, LLC.
What is the FDA product code for ZQuiet?
The FDA product code for ZQuiet 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.