Hypnos (369054-200)
K-Number: K250851 · 2025-12-14
ApplicantCadwell Industries, Inc.
Decision Date2025-12-14
Product CodeOLZ
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Hypnos (369054-200) is a medical device manufactured by Cadwell Industries, Inc.. It received FDA 510(k) clearance on 2025-12-14 under approval number K250851. The device is classified under product code OLZ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Hypnos (369054-200)?
Hypnos (369054-200) is a medical device that received FDA 510(k) clearance on 2025-12-14. It is manufactured by Cadwell Industries, Inc.. The 510(k) number is K250851.
When was Hypnos (369054-200) approved by the FDA?
Hypnos (369054-200) received FDA 510(k) clearance on 2025-12-14, under approval number K250851.
What company makes Hypnos (369054-200)?
Hypnos (369054-200) is manufactured by Cadwell Industries, Inc..
What is the FDA product code for Hypnos (369054-200)?
The FDA product code for Hypnos (369054-200) is OLZ.
Other Devices by Cadwell Industries, Inc.
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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.