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FDA 510(k)

MAICO MA800 AUDIOMETER

K-Number: K911368 · 1991-06-26

ApplicantMaico Hearing Instruments, Inc.
Decision Date1991-06-26
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

MAICO MA800 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 1991-06-26 under 510(k) number K911368. 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 MAICO MA800 AUDIOMETER?

MAICO MA800 AUDIOMETER is a medical device that received FDA 510(k) clearance on 1991-06-26. The listed applicant is Maico Hearing Instruments, Inc.. The 510(k) number is K911368.

When did MAICO MA800 AUDIOMETER receive FDA 510(k) clearance?

MAICO MA800 AUDIOMETER received FDA 510(k) clearance on 1991-06-26, under 510(k) number K911368.

Who is the listed applicant for MAICO MA800 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 MAICO MA800 AUDIOMETER?

The FDA product code for MAICO MA800 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.

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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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