Cleared Traditional

QScreen

K220139 · Path Medical GmbH · Ear, Nose, Throat
Aug 2022
Decision
197d
Days
Class 2
Risk

About This 510(k) Submission

K220139 is an FDA 510(k) clearance for the QScreen, a Stimulator, Auditory, Evoked Response (Class II — Special Controls, product code GWJ), submitted by Path Medical GmbH (Germering, DE). The FDA issued a Cleared decision on August 3, 2022, 197 days after receiving the submission on January 18, 2022. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 882.1900.

Submission Details

510(k) Number K220139 FDA.gov
FDA Decision Cleared SESE
Date Received January 18, 2022
Decision Date August 03, 2022
Days to Decision 197 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

Device Classification

Product Code GWJ — Stimulator, Auditory, Evoked Response
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1900

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