Cleared Traditional

SOMNOTOUCH RESP

K140861 · Somnomedics GmbH · Anesthesiology
Jan 2015
Decision
302d
Days
Class 2
Risk

About This 510(k) Submission

K140861 is an FDA 510(k) clearance for the SOMNOTOUCH RESP, a Ventilatory Effort Recorder (Class II — Special Controls, product code MNR), submitted by Somnomedics GmbH (Randersacker, DE). The FDA issued a Cleared decision on January 30, 2015, 302 days after receiving the submission on April 3, 2014. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2375.

Submission Details

510(k) Number K140861 FDA.gov
FDA Decision Cleared SESE
Date Received April 03, 2014
Decision Date January 30, 2015
Days to Decision 302 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