FDA 510(k)

SomnaPatch

K-Number: K183625 · 2019-10-18

Decision Date2019-10-18

Product CodeMNR

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

SomnaPatch is the device name listed in this FDA 510(k) record. The listed applicant is Respironics, Inc.. It received FDA 510(k) clearance on 2019-10-18 under 510(k) 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. The listed applicant is Respironics, Inc.. The 510(k) number is K183625.

When did SomnaPatch receive FDA 510(k) clearance?

SomnaPatch received FDA 510(k) clearance on 2019-10-18, under 510(k) number K183625.

Who is the listed applicant for SomnaPatch?

The FDA 510(k) record lists Respironics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SomnaPatch?

The FDA product code for SomnaPatch is MNR.

Other records listing Respironics, Inc. as applicant

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.