FDA 510(k)

QScreen

K-Number: K220139 · 2022-08-03

Decision Date2022-08-03

Product CodeGWJ

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

QScreen is the device name listed in this FDA 510(k) record. The listed applicant is Path Medical GmbH. It received FDA 510(k) clearance on 2022-08-03 under 510(k) 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. The listed applicant is Path Medical GmbH. The 510(k) number is K220139.

When did QScreen receive FDA 510(k) clearance?

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

Who is the listed applicant for QScreen?

The FDA 510(k) record lists Path Medical GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QScreen?

The FDA product code for QScreen is GWJ.

Other records listing Path Medical GmbH as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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

Related Devices (Code: GWJ)

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

Official Source

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