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FDA 510(k)

INTERACOUSTICS EP 15 ABR STAND ALONE UNIT

K-Number: K991853 · 1999-10-25

ApplicantIdem (Int'L Dist. of Electronics For Medicine)
Decision Date1999-10-25
Product CodeGWJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

INTERACOUSTICS EP 15 ABR STAND ALONE UNIT 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 1999-10-25 under 510(k) number K991853. The device is classified under product code GWJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTERACOUSTICS EP 15 ABR STAND ALONE UNIT?

INTERACOUSTICS EP 15 ABR STAND ALONE UNIT is a medical device that received FDA 510(k) clearance on 1999-10-25. The listed applicant is Idem (Int'L Dist. of Electronics For Medicine). The 510(k) number is K991853.

When did INTERACOUSTICS EP 15 ABR STAND ALONE UNIT receive FDA 510(k) clearance?

INTERACOUSTICS EP 15 ABR STAND ALONE UNIT received FDA 510(k) clearance on 1999-10-25, under 510(k) number K991853.

Who is the listed applicant for INTERACOUSTICS EP 15 ABR STAND ALONE UNIT?

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 EP 15 ABR STAND ALONE UNIT?

The FDA product code for INTERACOUSTICS EP 15 ABR STAND ALONE UNIT is GWJ.

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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.

K990652INTERACOUSTICS MODEL AZ26 CLINICAL IMPEDANCE AUDIOMETERK990585INTERACOUSTICS AT22T AUTOMATIC IMPEDANCE AUDIOMETERK983832INTERACOUSTICS MODEL MT 10, HANDHELD IMPEDANCE AUDIOMETERK982249INTERACOUSTICS MODEL AD229 DIAGNOSTIC AUDIOMETERK981327INTERACOUSTICS MODEL AD226 DIAGNOSTIC AUDIOMETER

Related Devices (Code: GWJ)

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.

K242954Integrity V500 (Integrity, Integrity with VEMP)Vivosonic, Inc.K233649ALGO Pro Newborn Hearing Screener (ALGO Pro)Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)K220139QScreenPath Medical GmbHK211147ALGO 7iPath Medical GmbHK193033GSI Audera ProGrason StadlerK163326SmartEPIntelligent Hearing Systems

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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