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FDA 510(k)

MA25 PORTABLE AUDIOMETER

K-Number: K853919 · 1985-12-18

ApplicantMaico Hearing Instruments, Inc.
Decision Date1985-12-18
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

MA25 PORTABLE AUDIOMETER 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 1985-12-18 under 510(k) number K853919. 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 MA25 PORTABLE AUDIOMETER?

MA25 PORTABLE AUDIOMETER is a medical device that received FDA 510(k) clearance on 1985-12-18. The listed applicant is Maico Hearing Instruments, Inc.. The 510(k) number is K853919.

When did MA25 PORTABLE AUDIOMETER receive FDA 510(k) clearance?

MA25 PORTABLE AUDIOMETER received FDA 510(k) clearance on 1985-12-18, under 510(k) number K853919.

Who is the listed applicant for MA25 PORTABLE AUDIOMETER?

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 MA25 PORTABLE AUDIOMETER?

The FDA product code for MA25 PORTABLE AUDIOMETER 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.

K960031AUDIOFLEX 120K954054MAICO PRODIGY CIC SERIESK953161MAICO MA630D AUDIOMETER WITH OPTIONAL REFLEX DECAY & EUSTACHIAN TUBE FUNCTIONK950637MAICO IN-THE-EAR MODEL RD-312 CICK946253MAICO IN-THE-EAR MODEL RD 201K931322KS 5 - CLINICAL AUDIOMETER

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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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