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FDA 510(k)

PORTABLE AUDIOMETERS

K-Number: K811727 · 1981-07-15

ApplicantMaico Hearing Instruments, Inc.
Decision Date1981-07-15
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

PORTABLE AUDIOMETERS 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 1981-07-15 under 510(k) number K811727. 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 PORTABLE AUDIOMETERS?

PORTABLE AUDIOMETERS is a medical device that received FDA 510(k) clearance on 1981-07-15. The listed applicant is Maico Hearing Instruments, Inc.. The 510(k) number is K811727.

When did PORTABLE AUDIOMETERS receive FDA 510(k) clearance?

PORTABLE AUDIOMETERS received FDA 510(k) clearance on 1981-07-15, under 510(k) number K811727.

Who is the listed applicant for PORTABLE AUDIOMETERS?

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 PORTABLE AUDIOMETERS?

The FDA product code for PORTABLE AUDIOMETERS 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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