Cleared Traditional

SomnaPatch

K183625 · Respironics, Inc. · Anesthesiology
Oct 2019
Decision
296d
Days
Class 2
Risk

About This 510(k) Submission

K183625 is an FDA 510(k) clearance for the SomnaPatch, a Ventilatory Effort Recorder (Class II — Special Controls, product code MNR), submitted by Respironics, Inc. (Murrysville, US). The FDA issued a Cleared decision on October 18, 2019, 296 days after receiving the submission on December 26, 2018. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2375.

Submission Details

510(k) Number K183625 FDA.gov
FDA Decision Cleared SESE
Date Received December 26, 2018
Decision Date October 18, 2019
Days to Decision 296 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code MNR — Ventilatory Effort Recorder
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.2375