Cleared Traditional

SENTIERO

K133012 · Path Medical GmbH · Ear, Nose, Throat
Jun 2014
Decision
257d
Days
Class 2
Risk

About This 510(k) Submission

K133012 is an FDA 510(k) clearance for the SENTIERO, a Audiometer (Class II — Special Controls, product code EWO), submitted by Path Medical GmbH (Germering, Bavaria, DE). The FDA issued a Cleared decision on June 9, 2014, 257 days after receiving the submission on September 25, 2013. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.1050.

Submission Details

510(k) Number K133012 FDA.gov
FDA Decision Cleared SESE
Date Received September 25, 2013
Decision Date June 09, 2014
Days to Decision 257 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

Device Classification

Product Code EWO — Audiometer
Device Class Class II — Special Controls
CFR Regulation 21 CFR 874.1050