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FDA 510(k)

IMMITTANCE METER, MODEL AE-105D/S

K-Number: K905212 · 1991-02-19

ApplicantAmerican Electromedics Corp.
Decision Date1991-02-19
Product CodeETY
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

IMMITTANCE METER, MODEL AE-105D/S is the device name listed in this FDA 510(k) record. The listed applicant is American Electromedics Corp.. It received FDA 510(k) clearance on 1991-02-19 under 510(k) number K905212. 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 IMMITTANCE METER, MODEL AE-105D/S?

IMMITTANCE METER, MODEL AE-105D/S is a medical device that received FDA 510(k) clearance on 1991-02-19. The listed applicant is American Electromedics Corp.. The 510(k) number is K905212.

When did IMMITTANCE METER, MODEL AE-105D/S receive FDA 510(k) clearance?

IMMITTANCE METER, MODEL AE-105D/S received FDA 510(k) clearance on 1991-02-19, under 510(k) number K905212.

Who is the listed applicant for IMMITTANCE METER, MODEL AE-105D/S?

The FDA 510(k) record lists American Electromedics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMMITTANCE METER, MODEL AE-105D/S?

The FDA product code for IMMITTANCE METER, MODEL AE-105D/S is ETY.

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Other records listing American Electromedics Corp. 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.

K983051AMERICAN ELECTROMEDICS RACE CA TYMPANOMETER/AUDIOMETER WITH INTEGRAL PRINTERK983049AMERICAN ELECTROMEDICS QUIK TYMP 1 (QT1) TYMPANOMETER WITH INTERGRAL PRINTERK983048AMERICAN ELECTROMEDICS QUIK TYMP 2 (QT2) TYMPANOMETER/AUDIOMETER WITH INTEGRAL PRINTERK983046AMERICAN ELECTROMEDICS RACE CAR TYMPANOMETER W/INTEGRAL PRINTERK972221K 15 AUDIOMETERK970279RACE CAR TYMPANOMETER WITH AUDIOMETER(AE-RCAUD I/QUIK TYMP 1(AE-QUIK 1)/QUICK TYMP 2(AE-QUIK 2)

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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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