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FDA 510(k)

EARPROBE

K-Number: K131141 · 2013-06-27

ApplicantPath Medical GmbH
Decision Date2013-06-27
Product CodeGWJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

EARPROBE 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 2013-06-27 under 510(k) number K131141. 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 EARPROBE?

EARPROBE is a medical device that received FDA 510(k) clearance on 2013-06-27. The listed applicant is Path Medical GmbH. The 510(k) number is K131141.

When did EARPROBE receive FDA 510(k) clearance?

EARPROBE received FDA 510(k) clearance on 2013-06-27, under 510(k) number K131141.

Who is the listed applicant for EARPROBE?

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 EARPROBE?

The FDA product code for EARPROBE is GWJ.

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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.

K220139QScreenK213345Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONEK211147ALGO 7iK100661EARPROBE

Related Devices (Code: GWJ)

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.

K242954Integrity V500 (Integrity, Integrity with VEMP)Vivosonic, Inc.K233649ALGO Pro Newborn Hearing Screener (ALGO Pro)Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)K220139QScreenPath Medical GmbHK211147ALGO 7iPath Medical GmbHK193033GSI Audera ProGrason StadlerK163326SmartEPIntelligent Hearing Systems

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.

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