Cleared Traditional

SOMNOLYZER 24X7

K131994 · Respironics, Inc. · Anesthesiology
Oct 2013
Decision
111d
Days
Class 2
Risk

About This 510(k) Submission

K131994 is an FDA 510(k) clearance for the SOMNOLYZER 24X7, 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 17, 2013, 111 days after receiving the submission on June 28, 2013. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2375.

Submission Details

510(k) Number K131994 FDA.gov
FDA Decision Cleared SESE
Date Received June 28, 2013
Decision Date October 17, 2013
Days to Decision 111 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