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FDA 510(k)

101, 151, 161 PORTABLE AUDIOMETERS

K-Number: K802963 · 1980-12-19

ApplicantAmplaid USA, Inc.
Decision Date1980-12-19
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

101, 151, 161 PORTABLE AUDIOMETERS is the device name listed in this FDA 510(k) record. The listed applicant is Amplaid USA, Inc.. It received FDA 510(k) clearance on 1980-12-19 under 510(k) number K802963. 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 101, 151, 161 PORTABLE AUDIOMETERS?

101, 151, 161 PORTABLE AUDIOMETERS is a medical device that received FDA 510(k) clearance on 1980-12-19. The listed applicant is Amplaid USA, Inc.. The 510(k) number is K802963.

When did 101, 151, 161 PORTABLE AUDIOMETERS receive FDA 510(k) clearance?

101, 151, 161 PORTABLE AUDIOMETERS received FDA 510(k) clearance on 1980-12-19, under 510(k) number K802963.

Who is the listed applicant for 101, 151, 161 PORTABLE AUDIOMETERS?

The FDA 510(k) record lists Amplaid USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 101, 151, 161 PORTABLE AUDIOMETERS?

The FDA product code for 101, 151, 161 PORTABLE AUDIOMETERS is EWO.

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Other records listing Amplaid USA, Inc. 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.

K861014AMPLAID MK15 (EVOKED POTENTIAL SYSTEM)K832510EVOKED POTENTIALS SYSTEM MK10K810482SOMATOSENSORY STIMULATORK810473MK6 ERA SYSTEMK810481VISUAL PATTERN REVERSAL GEN. & PHOTIC S.K802097SELF-RECORDING ADMITTANCE METER 709

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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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