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FDA 510(k)

INTERACOUSTICS MODEL AD229 DIAGNOSTIC AUDIOMETER

K-Number: K982249 · 1998-08-07

ApplicantIdem (Int'L Dist. of Electronics For Medicine)
Decision Date1998-08-07
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

INTERACOUSTICS MODEL AD229 DIAGNOSTIC 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 1998-08-07 under 510(k) number K982249. 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 MODEL AD229 DIAGNOSTIC AUDIOMETER?

INTERACOUSTICS MODEL AD229 DIAGNOSTIC AUDIOMETER is a medical device that received FDA 510(k) clearance on 1998-08-07. The listed applicant is Idem (Int'L Dist. of Electronics For Medicine). The 510(k) number is K982249.

When did INTERACOUSTICS MODEL AD229 DIAGNOSTIC AUDIOMETER receive FDA 510(k) clearance?

INTERACOUSTICS MODEL AD229 DIAGNOSTIC AUDIOMETER received FDA 510(k) clearance on 1998-08-07, under 510(k) number K982249.

Who is the listed applicant for INTERACOUSTICS MODEL AD229 DIAGNOSTIC 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 AD229 DIAGNOSTIC AUDIOMETER?

The FDA product code for INTERACOUSTICS MODEL AD229 DIAGNOSTIC AUDIOMETER is EWO.

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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 UNITK990652INTERACOUSTICS MODEL AZ26 CLINICAL IMPEDANCE AUDIOMETERK990585INTERACOUSTICS AT22T AUTOMATIC IMPEDANCE AUDIOMETERK983832INTERACOUSTICS MODEL MT 10, HANDHELD IMPEDANCE AUDIOMETERK981327INTERACOUSTICS MODEL AD226 DIAGNOSTIC AUDIOMETER

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

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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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