QScreen

FDA 510(k) K220139 · Path Medical GmbH

Substantially Equivalent

510(k) numberK220139

Submission

Device name
QScreen
Applicant
Path Medical GmbH
Germering, DE
Received
January 18, 2022
Decision date
August 3, 2022
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GWJ – Stimulator, Auditory, Evoked Response
Device class
Class II (moderate risk)
Regulation
21 CFR 882.1900
Specialty
Neurology

Other 510(k)s with product code GWJ

510(k)DeviceApplicantDecision
K242954Integrity V500 (Integrity, Integrity with VEMP)GWJ · Traditional Vivosonic, Inc.12/19/2024SE
K233649ALGO Pro Newborn Hearing Screener (ALGO Pro)GWJ · Traditional Natus Medical Incorporated Dba Excel-Tech Ltd.…03/08/2024SE
K211147ALGO 7iGWJ · Traditional Path Medical GmbH10/14/2021SE
K193033GSI Audera ProGWJ · Traditional Grason Stadler04/24/2020SE
K163326SmartEPGWJ · Traditional Intelligent Hearing Systems09/29/2017SE
K162037Eclipse with VEMPGWJ · Traditional Interacoustics A/S03/23/2017SE
K143670Ics Chartr Ep 200 with VempGWJ · Traditional Gn Otometrics A/S10/23/2015SE
K141446Echo-Screen III Pro Hearing Screener with Barcode Scanner, Echo-Screen III Pro Hearing…GWJ · Special Natus Medical Incorporated08/22/2014SE
K132957Madsen Accuscreen Type 1077GWJ · Traditional Gn Otometrics02/27/2014SE
K131141EarprobeGWJ · Traditional Path Medical GmbH06/27/2013SE

More from Path Medical GmbH

510(k)DeviceDecision
K213345Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONEEWO · Traditional 06/22/2022SE
K211147ALGO 7iGWJ · Traditional 10/14/2021SE
K133012SentieroEWO · Traditional 06/09/2014SE
K131141EarprobeGWJ · Traditional 06/27/2013SE
K100661EarprobeGWJ · Traditional 07/01/2010SE

Questions and answers

When was QScreen cleared by the FDA?

QScreen (K220139) received a 510(k) decision of Substantially Equivalent on August 3, 2022, 197 days after the submission was received.

What is the product code of K220139?

The FDA product code is GWJ – Stimulator, Auditory, Evoked Response, a Class II (moderate risk) device regulated under 21 CFR 882.1900.