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FDA 510(k)

AMPLAID A308 CLINICAL AUDIOMETER

K-Number: K891988 · 1989-10-12

ApplicantAmplus Corp.
Decision Date1989-10-12
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

AMPLAID A308 CLINICAL AUDIOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Amplus Corp.. It received FDA 510(k) clearance on 1989-10-12 under 510(k) number K891988. 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 AMPLAID A308 CLINICAL AUDIOMETER?

AMPLAID A308 CLINICAL AUDIOMETER is a medical device that received FDA 510(k) clearance on 1989-10-12. The listed applicant is Amplus Corp.. The 510(k) number is K891988.

When did AMPLAID A308 CLINICAL AUDIOMETER receive FDA 510(k) clearance?

AMPLAID A308 CLINICAL AUDIOMETER received FDA 510(k) clearance on 1989-10-12, under 510(k) number K891988.

Who is the listed applicant for AMPLAID A308 CLINICAL AUDIOMETER?

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

What is the FDA product code for AMPLAID A308 CLINICAL AUDIOMETER?

The FDA product code for AMPLAID A308 CLINICAL 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 Amplus 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.

K903066AMPLAID 770 ADMITTANCE METERK884071AMPLAID EMG15K880059AMPLAID 309 CLINICAL AUDIOMETER

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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