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FDA 510(k)

TYPE 1077 ACCUSCREEN

K-Number: K122067 · 2012-09-27

ApplicantGn Otometrics
Decision Date2012-09-27
Product CodeGWJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

TYPE 1077 ACCUSCREEN is the device name listed in this FDA 510(k) record. The listed applicant is Gn Otometrics. It received FDA 510(k) clearance on 2012-09-27 under 510(k) number K122067. 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 TYPE 1077 ACCUSCREEN?

TYPE 1077 ACCUSCREEN is a medical device that received FDA 510(k) clearance on 2012-09-27. The listed applicant is Gn Otometrics. The 510(k) number is K122067.

When did TYPE 1077 ACCUSCREEN receive FDA 510(k) clearance?

TYPE 1077 ACCUSCREEN received FDA 510(k) clearance on 2012-09-27, under 510(k) number K122067.

Who is the listed applicant for TYPE 1077 ACCUSCREEN?

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

What is the FDA product code for TYPE 1077 ACCUSCREEN?

The FDA product code for TYPE 1077 ACCUSCREEN is GWJ.

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Other records listing Gn Otometrics 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.

K161707Madsen ZodiacK122550ICS IMPULSEK122028AURICAL HITK092373ICS CHARTR EP 200K081234GN OTOMETRICS INSERT EARPHONES

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

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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