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FDA 510(k)

INTERACOUSTICS AUTOMATIC IMPEDANCE AUDIOMETER

K-Number: K942008 · 1994-08-24

ApplicantPrecision Acoustics Ind., Inc.
Decision Date1994-08-24
Product CodeETY
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

INTERACOUSTICS AUTOMATIC IMPEDANCE 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 1994-08-24 under 510(k) number K942008. The device is classified under product code ETY. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTERACOUSTICS AUTOMATIC IMPEDANCE AUDIOMETER?

INTERACOUSTICS AUTOMATIC IMPEDANCE AUDIOMETER is a medical device that received FDA 510(k) clearance on 1994-08-24. The listed applicant is Precision Acoustics Ind., Inc.. The 510(k) number is K942008.

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

INTERACOUSTICS AUTOMATIC IMPEDANCE AUDIOMETER received FDA 510(k) clearance on 1994-08-24, under 510(k) number K942008.

Who is the listed applicant for INTERACOUSTICS AUTOMATIC IMPEDANCE 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 AUTOMATIC IMPEDANCE AUDIOMETER?

The FDA product code for INTERACOUSTICS AUTOMATIC IMPEDANCE AUDIOMETER is ETY.

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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 20K943065INTERACOUSTICS CLINICAL AUDIOMETERK942006INTERACOUSTICS DIAGNOSTIC AUDIOMETER

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Related Devices (Code: ETY)

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.

K183201Hearing Healthcare ProDb Diagnostic Systems, Inc.K171038Hearing Healthcare ProDb Diagnostic Systems, Inc.K162210touchTympMaico Diagnostics GmbHK161707Madsen ZodiacGn OtometricsK121847TITANInteracoustics A/SK083861TITAN, TITAN SHOULDER BOX, TITAN CRADLE, TITAN PRINTER, TITAN IMP440, IMP440 MODULE, TITAN SUITEInteracoustics AS

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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