Hushd Pro Z-Link
K-Number: K251784 · 2025-10-24
ApplicantGood Sleep CO Pte , Ltd.
Decision Date2025-10-24
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Hushd Pro Z-Link is a medical device manufactured by Good Sleep CO Pte , Ltd.. It received FDA 510(k) clearance on 2025-10-24 under approval number K251784. 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 Z-Link?
Hushd Pro Z-Link is a medical device that received FDA 510(k) clearance on 2025-10-24. It is manufactured by Good Sleep CO Pte , Ltd.. The 510(k) number is K251784.
When was Hushd Pro Z-Link approved by the FDA?
Hushd Pro Z-Link received FDA 510(k) clearance on 2025-10-24, under approval number K251784.
What company makes Hushd Pro Z-Link?
Hushd Pro Z-Link is manufactured by Good Sleep CO Pte , Ltd..
What is the FDA product code for Hushd Pro Z-Link?
The FDA product code for Hushd Pro Z-Link 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.