Cleared Traditional

Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONE

K213345 · Path Medical GmbH · Ear, Nose, Throat

Jun 2022

Decision

257d

Days

Class 2

Risk

About This 510(k) Submission

K213345 is an FDA 510(k) clearance for the Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONE, a Audiometer (Class II — Special Controls, product code EWO), submitted by Path Medical GmbH (Germering, DE). The FDA issued a Cleared decision on June 22, 2022, 257 days after receiving the submission on October 8, 2021. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.1050.

Submission Details

510(k) Number	K213345 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 08, 2021
Decision Date	June 22, 2022
Days to Decision	257 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF