Hushd Avera
K-Number: K252161 · 2025-11-25
ApplicantGood Sleep CO Pte , Ltd.
Decision Date2025-11-25
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Hushd Avera is a medical device manufactured by Good Sleep CO Pte , Ltd.. It received FDA 510(k) clearance on 2025-11-25 under approval number K252161. 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 Hushd Avera?
Hushd Avera is a medical device that received FDA 510(k) clearance on 2025-11-25. It is manufactured by Good Sleep CO Pte , Ltd.. The 510(k) number is K252161.
When was Hushd Avera approved by the FDA?
Hushd Avera received FDA 510(k) clearance on 2025-11-25, under approval number K252161.
What company makes Hushd Avera?
Hushd Avera is manufactured by Good Sleep CO Pte , Ltd..
What is the FDA product code for Hushd Avera?
The FDA product code for Hushd Avera is LRK.
Other Devices by Good Sleep CO Pte , Ltd.
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.