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FDA 510(k)

INTERACOUSTICS MODEL AZ26 CLINICAL IMPEDANCE AUDIOMETER

K-Number: K990652 · 1999-05-17

ApplicantIdem (Int'L Dist. of Electronics For Medicine)
Decision Date1999-05-17
Product CodeETY
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

INTERACOUSTICS MODEL AZ26 CLINICAL IMPEDANCE AUDIOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Idem (Int'L Dist. of Electronics For Medicine). It received FDA 510(k) clearance on 1999-05-17 under 510(k) number K990652. 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 MODEL AZ26 CLINICAL IMPEDANCE AUDIOMETER?

INTERACOUSTICS MODEL AZ26 CLINICAL IMPEDANCE AUDIOMETER is a medical device that received FDA 510(k) clearance on 1999-05-17. The listed applicant is Idem (Int'L Dist. of Electronics For Medicine). The 510(k) number is K990652.

When did INTERACOUSTICS MODEL AZ26 CLINICAL IMPEDANCE AUDIOMETER receive FDA 510(k) clearance?

INTERACOUSTICS MODEL AZ26 CLINICAL IMPEDANCE AUDIOMETER received FDA 510(k) clearance on 1999-05-17, under 510(k) number K990652.

Who is the listed applicant for INTERACOUSTICS MODEL AZ26 CLINICAL IMPEDANCE AUDIOMETER?

The FDA 510(k) record lists Idem (Int'L Dist. of Electronics For Medicine) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INTERACOUSTICS MODEL AZ26 CLINICAL IMPEDANCE AUDIOMETER?

The FDA product code for INTERACOUSTICS MODEL AZ26 CLINICAL IMPEDANCE AUDIOMETER is ETY.

Related Clinical Trials

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Other records listing Idem (Int'L Dist. of Electronics For Medicine) 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.

K991853INTERACOUSTICS EP 15 ABR STAND ALONE UNITK990585INTERACOUSTICS AT22T AUTOMATIC IMPEDANCE AUDIOMETERK983832INTERACOUSTICS MODEL MT 10, HANDHELD IMPEDANCE AUDIOMETERK982249INTERACOUSTICS MODEL AD229 DIAGNOSTIC AUDIOMETERK981327INTERACOUSTICS MODEL AD226 DIAGNOSTIC AUDIOMETER

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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