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FDA 510(k)

MA630 IMPED SCREENER/MA640 IMPED/AUDIOMET SCREENER

K-Number: K905704 · 1991-04-30

ApplicantMaico Hearing Instruments, Inc.
Decision Date1991-04-30
Product CodeETY
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

MA630 IMPED SCREENER/MA640 IMPED/AUDIOMET SCREENER 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 1991-04-30 under 510(k) number K905704. The device is classified under product code ETY. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MA630 IMPED SCREENER/MA640 IMPED/AUDIOMET SCREENER?

MA630 IMPED SCREENER/MA640 IMPED/AUDIOMET SCREENER is a medical device that received FDA 510(k) clearance on 1991-04-30. The listed applicant is Maico Hearing Instruments, Inc.. The 510(k) number is K905704.

When did MA630 IMPED SCREENER/MA640 IMPED/AUDIOMET SCREENER receive FDA 510(k) clearance?

MA630 IMPED SCREENER/MA640 IMPED/AUDIOMET SCREENER received FDA 510(k) clearance on 1991-04-30, under 510(k) number K905704.

Who is the listed applicant for MA630 IMPED SCREENER/MA640 IMPED/AUDIOMET SCREENER?

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 MA630 IMPED SCREENER/MA640 IMPED/AUDIOMET SCREENER?

The FDA product code for MA630 IMPED SCREENER/MA640 IMPED/AUDIOMET SCREENER is ETY.

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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: ETY)

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.

K183201Hearing Healthcare ProDb Diagnostic Systems, Inc.K171038Hearing Healthcare ProDb Diagnostic Systems, Inc.K162210touchTympMaico Diagnostics GmbHK161707Madsen ZodiacGn OtometricsK121847TITANInteracoustics A/SK083861TITAN, TITAN SHOULDER BOX, TITAN CRADLE, TITAN PRINTER, TITAN IMP440, IMP440 MODULE, TITAN SUITEInteracoustics AS

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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