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FDA 510(k)

SPORT/AUDX OAE TEST INSTRUMENT WITH BIO-LOGIC EAR PROBE

K-Number: K974076 · 1998-01-22

ApplicantBio-Logic Systems Corp.
Decision Date1998-01-22
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

SPORT/AUDX OAE TEST INSTRUMENT WITH BIO-LOGIC EAR PROBE 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 1998-01-22 under 510(k) number K974076. 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 SPORT/AUDX OAE TEST INSTRUMENT WITH BIO-LOGIC EAR PROBE?

SPORT/AUDX OAE TEST INSTRUMENT WITH BIO-LOGIC EAR PROBE is a medical device that received FDA 510(k) clearance on 1998-01-22. The listed applicant is Bio-Logic Systems Corp.. The 510(k) number is K974076.

When did SPORT/AUDX OAE TEST INSTRUMENT WITH BIO-LOGIC EAR PROBE receive FDA 510(k) clearance?

SPORT/AUDX OAE TEST INSTRUMENT WITH BIO-LOGIC EAR PROBE received FDA 510(k) clearance on 1998-01-22, under 510(k) number K974076.

Who is the listed applicant for SPORT/AUDX OAE TEST INSTRUMENT WITH BIO-LOGIC EAR PROBE?

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 SPORT/AUDX OAE TEST INSTRUMENT WITH BIO-LOGIC EAR PROBE?

The FDA product code for SPORT/AUDX OAE TEST INSTRUMENT WITH BIO-LOGIC EAR PROBE is EWO.

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Other records listing Bio-Logic Systems Corp. as applicant

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K122496AUDX PRO OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEMK121512SCOUT SPORT OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEMK073626BIO-LOGIC MASTER II EVOKED RESPONSE SYSTEMK061744COCHLEA-SCAN / COCHLEA-SCAN PLUSK052066CEEGRAPH/SLEEPSCAN NETLINK TRAVELERK031352BIO-LOGIC INSERT EARPHONES

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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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