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FDA 510(k)

EARSCAN DSP-1 PURE TONE AUDIOMETER

K-Number: K913589 · 1991-11-05

ApplicantMicro Audiometrics Corp.
Decision Date1991-11-05
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

EARSCAN DSP-1 PURE TONE 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 1991-11-05 under 510(k) number K913589. 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 DSP-1 PURE TONE AUDIOMETER?

EARSCAN DSP-1 PURE TONE AUDIOMETER is a medical device that received FDA 510(k) clearance on 1991-11-05. The listed applicant is Micro Audiometrics Corp.. The 510(k) number is K913589.

When did EARSCAN DSP-1 PURE TONE AUDIOMETER receive FDA 510(k) clearance?

EARSCAN DSP-1 PURE TONE AUDIOMETER received FDA 510(k) clearance on 1991-11-05, under 510(k) number K913589.

Who is the listed applicant for EARSCAN DSP-1 PURE TONE 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 EARSCAN DSP-1 PURE TONE AUDIOMETER?

The FDA product code for EARSCAN DSP-1 PURE TONE AUDIOMETER 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.

K982878EARSCAN 3K924543DSP SCREENING 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

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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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