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FDA 510(k)

AUDX PRO OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM

K-Number: K122496 · 2012-11-01

ApplicantBio-Logic Systems Corp.
Decision Date2012-11-01
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

AUDX PRO OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Logic Systems Corp.. It received FDA 510(k) clearance on 2012-11-01 under 510(k) number K122496. The device is classified under product code EWO. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUDX PRO OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM?

AUDX PRO OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM is a medical device that received FDA 510(k) clearance on 2012-11-01. The listed applicant is Bio-Logic Systems Corp.. The 510(k) number is K122496.

When did AUDX PRO OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM receive FDA 510(k) clearance?

AUDX PRO OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM received FDA 510(k) clearance on 2012-11-01, under 510(k) number K122496.

Who is the listed applicant for AUDX PRO OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM?

The FDA 510(k) record lists Bio-Logic Systems Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AUDX PRO OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM?

The FDA product code for AUDX PRO OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM is EWO.

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Other records listing Bio-Logic Systems Corp. 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.

K121512SCOUT SPORT OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEMK073626BIO-LOGIC MASTER II EVOKED RESPONSE SYSTEMK061744COCHLEA-SCAN / COCHLEA-SCAN PLUSK052066CEEGRAPH/SLEEPSCAN NETLINK TRAVELERK031352BIO-LOGIC INSERT EARPHONESK030907STACKED ABR FOR NAVIGATOR PRO

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Related Devices (Code: EWO)

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.

K234095OtoNova/OtoNova ProOtodynamicsK240430Otoport ProOtodynamics, Ltd.K231545hearOAEHearx SA (Pty) , Ltd.K213345Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONEPath Medical GmbHK191372LyraInteracoustics A/SK180287GSI CortiGrason-Stadler, Inc.

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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