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FDA 510(k)

AUTO IMPEDANCE METER AE105 & AE106 W/AUDIOMETER

K-Number: K883728 · 1989-01-03

ApplicantAmerican Electromedics Corp.
Decision Date1989-01-03
Product CodeETY
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

AUTO IMPEDANCE METER AE105 & AE106 W/AUDIOMETER 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 1989-01-03 under 510(k) number K883728. 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 AUTO IMPEDANCE METER AE105 & AE106 W/AUDIOMETER?

AUTO IMPEDANCE METER AE105 & AE106 W/AUDIOMETER is a medical device that received FDA 510(k) clearance on 1989-01-03. The listed applicant is American Electromedics Corp.. The 510(k) number is K883728.

When did AUTO IMPEDANCE METER AE105 & AE106 W/AUDIOMETER receive FDA 510(k) clearance?

AUTO IMPEDANCE METER AE105 & AE106 W/AUDIOMETER received FDA 510(k) clearance on 1989-01-03, under 510(k) number K883728.

Who is the listed applicant for AUTO IMPEDANCE METER AE105 & AE106 W/AUDIOMETER?

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 AUTO IMPEDANCE METER AE105 & AE106 W/AUDIOMETER?

The FDA product code for AUTO IMPEDANCE METER AE105 & AE106 W/AUDIOMETER is ETY.

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Other records listing American Electromedics Corp. as applicant

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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)

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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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