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FDA 510(k)

AE-207D TYMPANOMETER

K-Number: K930165 · 1993-04-23

ApplicantAmrex Electronics, Inc.
Decision Date1993-04-23
Product CodeETY
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

AE-207D TYMPANOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Amrex Electronics, Inc.. It received FDA 510(k) clearance on 1993-04-23 under 510(k) number K930165. 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 AE-207D TYMPANOMETER?

AE-207D TYMPANOMETER is a medical device that received FDA 510(k) clearance on 1993-04-23. The listed applicant is Amrex Electronics, Inc.. The 510(k) number is K930165.

When did AE-207D TYMPANOMETER receive FDA 510(k) clearance?

AE-207D TYMPANOMETER received FDA 510(k) clearance on 1993-04-23, under 510(k) number K930165.

Who is the listed applicant for AE-207D TYMPANOMETER?

The FDA 510(k) record lists Amrex Electronics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AE-207D TYMPANOMETER?

The FDA product code for AE-207D TYMPANOMETER is ETY.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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