Hushd Pro Avera
K-Number: K232025 · 2024-05-09
ApplicantGood Sleep CO Pte , Ltd.
Decision Date2024-05-09
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Hushd Pro Avera is a medical device manufactured by Good Sleep CO Pte , Ltd.. It received FDA 510(k) clearance on 2024-05-09 under approval number K232025. 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 Pro Avera?
Hushd Pro Avera is a medical device that received FDA 510(k) clearance on 2024-05-09. It is manufactured by Good Sleep CO Pte , Ltd.. The 510(k) number is K232025.
When was Hushd Pro Avera approved by the FDA?
Hushd Pro Avera received FDA 510(k) clearance on 2024-05-09, under approval number K232025.
What company makes Hushd Pro Avera?
Hushd Pro Avera is manufactured by Good Sleep CO Pte , Ltd..
What is the FDA product code for Hushd Pro Avera?
The FDA product code for Hushd Pro 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.