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FDA 510(k)

AUDIOMETER, MA30, AIR & BONE CONDUCTION

K-Number: K770617 · 1977-04-07

ApplicantMaico Hearing Instruments, Inc.
Decision Date1977-04-07
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

AUDIOMETER, MA30, AIR & BONE CONDUCTION is the device name listed in this FDA 510(k) record. The listed applicant is Maico Hearing Instruments, Inc.. It received FDA 510(k) clearance on 1977-04-07 under 510(k) number K770617. 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, MA30, AIR & BONE CONDUCTION?

AUDIOMETER, MA30, AIR & BONE CONDUCTION is a medical device that received FDA 510(k) clearance on 1977-04-07. The listed applicant is Maico Hearing Instruments, Inc.. The 510(k) number is K770617.

When did AUDIOMETER, MA30, AIR & BONE CONDUCTION receive FDA 510(k) clearance?

AUDIOMETER, MA30, AIR & BONE CONDUCTION received FDA 510(k) clearance on 1977-04-07, under 510(k) number K770617.

Who is the listed applicant for AUDIOMETER, MA30, AIR & BONE CONDUCTION?

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

What is the FDA product code for AUDIOMETER, MA30, AIR & BONE CONDUCTION?

The FDA product code for AUDIOMETER, MA30, AIR & BONE CONDUCTION is EWO.

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Other records listing Maico Hearing Instruments, 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.

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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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