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FDA 510(k)

BIOMETER AUDIOMETER

K-Number: K883505 · 1989-08-21

ApplicantMicro Audiometrics Corp.
Decision Date1989-08-21
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

BIOMETER 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 1989-08-21 under 510(k) number K883505. 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 BIOMETER AUDIOMETER?

BIOMETER AUDIOMETER is a medical device that received FDA 510(k) clearance on 1989-08-21. The listed applicant is Micro Audiometrics Corp.. The 510(k) number is K883505.

When did BIOMETER AUDIOMETER receive FDA 510(k) clearance?

BIOMETER AUDIOMETER received FDA 510(k) clearance on 1989-08-21, under 510(k) number K883505.

Who is the listed applicant for BIOMETER 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 BIOMETER AUDIOMETER?

The FDA product code for BIOMETER 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 AUDIOMETERK913589EARSCAN DSP-1 PURE TONE AUDIOMETERK904270BIOLINK AUDIOMETER SOFTWARE ACCESSORYK812529EARSCAN

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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