BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    INSERTION GAIN OPTIMIZER IGO-1000

    K Number: K854535 · Decision Feb 20, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    45
    Applicant Total
    17
    Review Days
    99

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    Basic Information

    Device Name
    INSERTION GAIN OPTIMIZER IGO-1000
    K Number
    K854535
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3310
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Madsen Electronics (Canada) , Ltd.
    Date Received
    November 13, 1985
    Decision Date
    February 20, 1986
    Product Code
    ETW
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    ETW Calibrator, Hearing Aid / Earphone And Analysis Systems

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    Other Clearances by Madsen Electronics (Canada) , Ltd.

    K Number Device Name
    K942749 HI-PRO/NOAH UNIVERSAL HEARING INSTRUMENT
    K931325 OTOACOUSTIC EMISSIONS UNIT CELESTA 503
    K931324 ORBITER 922 CLINICAL AUDIOMETER
    K910247 ZODIAC 901 MIDDLE-EAR ANALYZER
    K884372 MADSEN IGO1500 INSERTION GAIN OPTIMIZER
    K884371 MADSEN IGO-HAT1500 HEARING AID DISPENSER SYSTEM
    K883478 DIAGNOSTIC AUDIOMETER, MODEL MIDIMATE 602
    K874354 AUDIOMETRIC IMPEDANCE TESTER, MODEL Z02020
    K870229 HEARING AID TEST SYSTEM MODEL HAT 1000
    K861905 PLOTTER MODEL (MP100)
    Search all 17 clearances from Madsen Electronics (Canada) , Ltd. →