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FDA 510(k)

COMPUTER AUDIOMETER - MA26

K-Number: K780270 · 1978-02-27

ApplicantMaico Hearing Instruments, Inc.
Decision Date1978-02-27
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

COMPUTER AUDIOMETER - MA26 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 1978-02-27 under 510(k) number K780270. 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 COMPUTER AUDIOMETER - MA26?

COMPUTER AUDIOMETER - MA26 is a medical device that received FDA 510(k) clearance on 1978-02-27. The listed applicant is Maico Hearing Instruments, Inc.. The 510(k) number is K780270.

When did COMPUTER AUDIOMETER - MA26 receive FDA 510(k) clearance?

COMPUTER AUDIOMETER - MA26 received FDA 510(k) clearance on 1978-02-27, under 510(k) number K780270.

Who is the listed applicant for COMPUTER AUDIOMETER - MA26?

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 COMPUTER AUDIOMETER - MA26?

The FDA product code for COMPUTER AUDIOMETER - MA26 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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