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FDA 510(k)

QScreen

K-Number: K220139 · 2022-08-03

ApplicantPath Medical GmbH
Decision Date2022-08-03
Product CodeGWJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

QScreen is a medical device manufactured by Path Medical GmbH. It received FDA 510(k) clearance on 2022-08-03 under approval number K220139. The device is classified under product code GWJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QScreen?

QScreen is a medical device that received FDA 510(k) clearance on 2022-08-03. It is manufactured by Path Medical GmbH. The 510(k) number is K220139.

When was QScreen approved by the FDA?

QScreen received FDA 510(k) clearance on 2022-08-03, under approval number K220139.

What company makes QScreen?

QScreen is manufactured by Path Medical GmbH.

What is the FDA product code for QScreen?

The FDA product code for QScreen is GWJ.

Other Devices by Path Medical GmbH

K211147ALGO 7i K213345Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONE

Related Devices (Code: GWJ)

K163326SmartEPIntelligent Hearing Systems K162037Eclipse with VEMPInteracoustics A/S K193033GSI Audera ProGrason Stadler K211147ALGO 7iPath Medical GmbH K242954Integrity V500 (Integrity, Integrity with VEMP)Vivosonic, Inc. K233649ALGO Pro Newborn Hearing Screener (ALGO Pro)Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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