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FDA 510(k)

AUDIOMETER, OTOACOUSTIC EMISSION, AUDITORY BRANSTEM RESPONSE ACCESS

K-Number: K031713 · 2003-08-12

ApplicantViasys Healthcare, Inc.
Decision Date2003-08-12
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

AUDIOMETER, OTOACOUSTIC EMISSION, AUDITORY BRANSTEM RESPONSE ACCESS is the device name listed in this FDA 510(k) record. The listed applicant is Viasys Healthcare, Inc.. It received FDA 510(k) clearance on 2003-08-12 under 510(k) number K031713. 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 AUDIOMETER, OTOACOUSTIC EMISSION, AUDITORY BRANSTEM RESPONSE ACCESS?

AUDIOMETER, OTOACOUSTIC EMISSION, AUDITORY BRANSTEM RESPONSE ACCESS is a medical device that received FDA 510(k) clearance on 2003-08-12. The listed applicant is Viasys Healthcare, Inc.. The 510(k) number is K031713.

When did AUDIOMETER, OTOACOUSTIC EMISSION, AUDITORY BRANSTEM RESPONSE ACCESS receive FDA 510(k) clearance?

AUDIOMETER, OTOACOUSTIC EMISSION, AUDITORY BRANSTEM RESPONSE ACCESS received FDA 510(k) clearance on 2003-08-12, under 510(k) number K031713.

Who is the listed applicant for AUDIOMETER, OTOACOUSTIC EMISSION, AUDITORY BRANSTEM RESPONSE ACCESS?

The FDA 510(k) record lists Viasys Healthcare, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AUDIOMETER, OTOACOUSTIC EMISSION, AUDITORY BRANSTEM RESPONSE ACCESS?

The FDA product code for AUDIOMETER, OTOACOUSTIC EMISSION, AUDITORY BRANSTEM RESPONSE ACCESS is EWO.

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Other records listing Viasys Healthcare, Inc. 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.

K060421SONARA; SONARA/TEKK030517BALL RECORDING ELECTRODE/STIMULATION PROBE

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

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