Rest Assure System
K-Number: K233497 · 2024-10-03
ApplicantSomnomed, Inc.
Decision Date2024-10-03
Product CodePLC
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Rest Assure System is a medical device manufactured by Somnomed, Inc.. It received FDA 510(k) clearance on 2024-10-03 under approval number K233497. The device is classified under product code PLC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Rest Assure System?
Rest Assure System is a medical device that received FDA 510(k) clearance on 2024-10-03. It is manufactured by Somnomed, Inc.. The 510(k) number is K233497.
When was Rest Assure System approved by the FDA?
Rest Assure System received FDA 510(k) clearance on 2024-10-03, under approval number K233497.
What company makes Rest Assure System?
Rest Assure System is manufactured by Somnomed, Inc..
What is the FDA product code for Rest Assure System?
The FDA product code for Rest Assure System is PLC.
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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.