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FDA 510(k)

INTERACOUSTICS CLINICAL AUDIOMETER

K-Number: K943065 · 1994-08-17

ApplicantPrecision Acoustics Ind., Inc.
Decision Date1994-08-17
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

INTERACOUSTICS CLINICAL AUDIOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Precision Acoustics Ind., Inc.. It received FDA 510(k) clearance on 1994-08-17 under 510(k) number K943065. 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 INTERACOUSTICS CLINICAL AUDIOMETER?

INTERACOUSTICS CLINICAL AUDIOMETER is a medical device that received FDA 510(k) clearance on 1994-08-17. The listed applicant is Precision Acoustics Ind., Inc.. The 510(k) number is K943065.

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

INTERACOUSTICS CLINICAL AUDIOMETER received FDA 510(k) clearance on 1994-08-17, under 510(k) number K943065.

Who is the listed applicant for INTERACOUSTICS CLINICAL AUDIOMETER?

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

What is the FDA product code for INTERACOUSTICS CLINICAL AUDIOMETER?

The FDA product code for INTERACOUSTICS CLINICAL AUDIOMETER is EWO.

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Other records listing Precision Acoustics Ind., 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.

K943607INTERACOUSTICS HEARING AID ANALYZER MS 40K941920INTERACOUSTICS CLINICAL AUDIOMETERK942007INTERACOUSTICS CLINICAL IMPEDANCE AUDIOMETER AZ26K943066INTERACOUSTICS COMPUTER AUDIOMETER BA 20K942008INTERACOUSTICS AUTOMATIC IMPEDANCE AUDIOMETERK942006INTERACOUSTICS DIAGNOSTIC AUDIOMETER

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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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