FDA 510(k)

DSP SCREENING AUDIOMETER

K-Number: K924543 · 1993-02-26

Decision Date1993-02-26

Product CodeEWO

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

DSP SCREENING AUDIOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Micro Audiometrics Corp.. It received FDA 510(k) clearance on 1993-02-26 under 510(k) number K924543. 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 DSP SCREENING AUDIOMETER?

DSP SCREENING AUDIOMETER is a medical device that received FDA 510(k) clearance on 1993-02-26. The listed applicant is Micro Audiometrics Corp.. The 510(k) number is K924543.

When did DSP SCREENING AUDIOMETER receive FDA 510(k) clearance?

DSP SCREENING AUDIOMETER received FDA 510(k) clearance on 1993-02-26, under 510(k) number K924543.

Who is the listed applicant for DSP SCREENING AUDIOMETER?

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

What is the FDA product code for DSP SCREENING AUDIOMETER?

The FDA product code for DSP SCREENING AUDIOMETER is EWO.

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Other records listing Micro Audiometrics Corp. as applicant

K982878EARSCAN 3 K913589EARSCAN DSP-1 PURE TONE AUDIOMETER K904270BIOLINK AUDIOMETER SOFTWARE ACCESSORY K883505BIOMETER AUDIOMETER K812529EARSCAN

Related Devices (Code: EWO)

K234095OtoNova/OtoNova ProOtodynamics K240430Otoport ProOtodynamics, Ltd.K231545hearOAEHearx SA (Pty) , Ltd.K213345Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONEPath Medical GmbH K191372LyraInteracoustics A/S K180287GSI CortiGrason-Stadler, Inc.

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.