Cleared Traditional

SOMNOWATCH

K081485 · Somnomedics GmbH · Anesthesiology
Sep 2008
Decision
113d
Days
Class 2
Risk

About This 510(k) Submission

K081485 is an FDA 510(k) clearance for the SOMNOWATCH, a Ventilatory Effort Recorder (Class II — Special Controls, product code MNR), submitted by Somnomedics GmbH (Alexandria, US). The FDA issued a Cleared decision on September 18, 2008, 113 days after receiving the submission on May 28, 2008. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2375.

Submission Details

510(k) Number K081485 FDA.gov
FDA Decision Cleared SESE
Date Received May 28, 2008
Decision Date September 18, 2008
Days to Decision 113 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