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FDA 510(k)

INTERACOUSTICS AT235 IMPEDANCE AUDIOMETER

K-Number: K994254 · 2000-03-14

ApplicantInternational Distributors of Electronics For Medi
Decision Date2000-03-14
Product CodeETY
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

INTERACOUSTICS AT235 IMPEDANCE AUDIOMETER is the device name listed in this FDA 510(k) record. The listed applicant is International Distributors of Electronics For Medi. It received FDA 510(k) clearance on 2000-03-14 under 510(k) number K994254. 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 AT235 IMPEDANCE AUDIOMETER?

INTERACOUSTICS AT235 IMPEDANCE AUDIOMETER is a medical device that received FDA 510(k) clearance on 2000-03-14. The listed applicant is International Distributors of Electronics For Medi. The 510(k) number is K994254.

When did INTERACOUSTICS AT235 IMPEDANCE AUDIOMETER receive FDA 510(k) clearance?

INTERACOUSTICS AT235 IMPEDANCE AUDIOMETER received FDA 510(k) clearance on 2000-03-14, under 510(k) number K994254.

Who is the listed applicant for INTERACOUSTICS AT235 IMPEDANCE AUDIOMETER?

The FDA 510(k) record lists International Distributors of Electronics For Medi as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INTERACOUSTICS AT235 IMPEDANCE AUDIOMETER?

The FDA product code for INTERACOUSTICS AT235 IMPEDANCE AUDIOMETER is ETY.

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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

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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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