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FDA 510(k)

AUDIOMETER/MASTER HEARING AID MF6

K-Number: K862770 · 1986-08-15

ApplicantMaico Hearing Instruments, Inc.
Decision Date1986-08-15
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

AUDIOMETER/MASTER HEARING AID MF6 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 1986-08-15 under 510(k) number K862770. 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/MASTER HEARING AID MF6?

AUDIOMETER/MASTER HEARING AID MF6 is a medical device that received FDA 510(k) clearance on 1986-08-15. The listed applicant is Maico Hearing Instruments, Inc.. The 510(k) number is K862770.

When did AUDIOMETER/MASTER HEARING AID MF6 receive FDA 510(k) clearance?

AUDIOMETER/MASTER HEARING AID MF6 received FDA 510(k) clearance on 1986-08-15, under 510(k) number K862770.

Who is the listed applicant for AUDIOMETER/MASTER HEARING AID MF6?

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/MASTER HEARING AID MF6?

The FDA product code for AUDIOMETER/MASTER HEARING AID MF6 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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