SomnaPatch
K-Number: K183625 · 2019-10-18
ApplicantRespironics, Inc.
Decision Date2019-10-18
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
SomnaPatch is a medical device manufactured by Respironics, Inc.. It received FDA 510(k) clearance on 2019-10-18 under approval number K183625. The device is classified under product code MNR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SomnaPatch?
SomnaPatch is a medical device that received FDA 510(k) clearance on 2019-10-18. It is manufactured by Respironics, Inc.. The 510(k) number is K183625.
When was SomnaPatch approved by the FDA?
SomnaPatch received FDA 510(k) clearance on 2019-10-18, under approval number K183625.
What company makes SomnaPatch?
SomnaPatch is manufactured by Respironics, Inc..
What is the FDA product code for SomnaPatch?
The FDA product code for SomnaPatch is MNR.
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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.