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FDA 510(k)

INTERACOUSTICS. HEARING AID ANALYZER

K-Number: K941848 · 1994-05-23

ApplicantPrecision Acoustics Ind., Inc.
Decision Date1994-05-23
Product CodeETW
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

INTERACOUSTICS. HEARING AID ANALYZER 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 1994-05-23 under 510(k) number K941848. The device is classified under product code ETW. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTERACOUSTICS. HEARING AID ANALYZER?

INTERACOUSTICS. HEARING AID ANALYZER is a medical device that received FDA 510(k) clearance on 1994-05-23. The listed applicant is Precision Acoustics Ind., Inc.. The 510(k) number is K941848.

When did INTERACOUSTICS. HEARING AID ANALYZER receive FDA 510(k) clearance?

INTERACOUSTICS. HEARING AID ANALYZER received FDA 510(k) clearance on 1994-05-23, under 510(k) number K941848.

Who is the listed applicant for INTERACOUSTICS. HEARING AID ANALYZER?

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. HEARING AID ANALYZER?

The FDA product code for INTERACOUSTICS. HEARING AID ANALYZER is ETW.

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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 AUDIOMETERK943065INTERACOUSTICS CLINICAL AUDIOMETER

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Related Devices (Code: ETW)

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.

K122028AURICAL HITGn OtometricsK113831PRIMUS HEARING INSTRUMENT TEST UNITAuditdata A/SK110286GN OTOMETRICS TYPE 1053 FREEFITGn Otometrics A/SK093006FONIX ,MODEL 8000Frye Electronics, Inc.K071462UNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2)Siemens Hearing Instruments, Inc.K061104SPEECHLINK 100 TYPE 1053Gn Otometrics A/S

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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