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FDA 510(k)

OTOMETER PORTABLE SCREENING AUDIOMETER

K-Number: K883169 · 1988-12-07

ApplicantOtometer, Inc.
Decision Date1988-12-07
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

OTOMETER PORTABLE SCREENING AUDIOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Otometer, Inc.. It received FDA 510(k) clearance on 1988-12-07 under 510(k) number K883169. 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 OTOMETER PORTABLE SCREENING AUDIOMETER?

OTOMETER PORTABLE SCREENING AUDIOMETER is a medical device that received FDA 510(k) clearance on 1988-12-07. The listed applicant is Otometer, Inc.. The 510(k) number is K883169.

When did OTOMETER PORTABLE SCREENING AUDIOMETER receive FDA 510(k) clearance?

OTOMETER PORTABLE SCREENING AUDIOMETER received FDA 510(k) clearance on 1988-12-07, under 510(k) number K883169.

Who is the listed applicant for OTOMETER PORTABLE SCREENING AUDIOMETER?

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

What is the FDA product code for OTOMETER PORTABLE SCREENING AUDIOMETER?

The FDA product code for OTOMETER PORTABLE SCREENING AUDIOMETER is EWO.

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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

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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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