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FDA 510(k)

EARSCAN 3

K-Number: K982878 · 1998-11-03

ApplicantMicro Audiometrics Corp.
Decision Date1998-11-03
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

EARSCAN 3 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 1998-11-03 under 510(k) number K982878. 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 EARSCAN 3?

EARSCAN 3 is a medical device that received FDA 510(k) clearance on 1998-11-03. The listed applicant is Micro Audiometrics Corp.. The 510(k) number is K982878.

When did EARSCAN 3 receive FDA 510(k) clearance?

EARSCAN 3 received FDA 510(k) clearance on 1998-11-03, under 510(k) number K982878.

Who is the listed applicant for EARSCAN 3?

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 EARSCAN 3?

The FDA product code for EARSCAN 3 is EWO.

Related Clinical Trials

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.

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Other records listing Micro Audiometrics 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.

K924543DSP SCREENING AUDIOMETERK913589EARSCAN DSP-1 PURE TONE AUDIOMETERK904270BIOLINK AUDIOMETER SOFTWARE ACCESSORYK883505BIOMETER AUDIOMETERK812529EARSCAN

Related Devices (Code: EWO)

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.

K234095OtoNova/OtoNova ProOtodynamicsK240430Otoport ProOtodynamics, Ltd.K231545hearOAEHearx SA (Pty) , Ltd.K213345Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONEPath Medical GmbHK191372LyraInteracoustics A/SK180287GSI CortiGrason-Stadler, Inc.

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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