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FDA 510(k)

HINT AUDIOMETER, OR HINT

K-Number: K003913 · 2001-03-16

ApplicantMaico-Diagnostics
Decision Date2001-03-16
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

HINT AUDIOMETER, OR HINT is the device name listed in this FDA 510(k) record. The listed applicant is Maico-Diagnostics. It received FDA 510(k) clearance on 2001-03-16 under 510(k) number K003913. 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 HINT AUDIOMETER, OR HINT?

HINT AUDIOMETER, OR HINT is a medical device that received FDA 510(k) clearance on 2001-03-16. The listed applicant is Maico-Diagnostics. The 510(k) number is K003913.

When did HINT AUDIOMETER, OR HINT receive FDA 510(k) clearance?

HINT AUDIOMETER, OR HINT received FDA 510(k) clearance on 2001-03-16, under 510(k) number K003913.

Who is the listed applicant for HINT AUDIOMETER, OR HINT?

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

What is the FDA product code for HINT AUDIOMETER, OR HINT?

The FDA product code for HINT AUDIOMETER, OR HINT is EWO.

Related Clinical Trials

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Other records listing Maico-Diagnostics 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.

K082035MAICO MB 11 WITH BERAPHONE PROBEK060885MODEL MI 44 TYMPANOMETER

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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