BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    INTERACOUSTICS DIAGNOSTIC AUDIOMETER

    K Number: K942006 · Decision Jun 20, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    62
    Registration Numbers
    62
    Same Product Code
    234
    Applicant Total
    9
    Review Days
    56

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    Basic Information

    Device Name
    INTERACOUSTICS DIAGNOSTIC AUDIOMETER
    K Number
    K942006
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.1050
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Precision Acoustics Ind., Inc.
    Date Received
    April 25, 1994
    Decision Date
    June 20, 1994
    Product Code
    EWO
    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
    EWO Audiometer

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    Other Clearances by Precision Acoustics Ind., Inc.

    K Number Device Name
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    K941920 INTERACOUSTICS CLINICAL AUDIOMETER
    K943066 INTERACOUSTICS COMPUTER AUDIOMETER BA 20
    K942008 INTERACOUSTICS AUTOMATIC IMPEDANCE AUDIOMETER
    K942007 INTERACOUSTICS CLINICAL IMPEDANCE AUDIOMETER AZ26
    K943065 INTERACOUSTICS CLINICAL AUDIOMETER
    K941848 INTERACOUSTICS. HEARING AID ANALYZER
    K930260 ACOUSTIC ANALYZER AA30