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

    MD5 AUTOMATIC AUDIOMETER

    K Number: K896909 · Decision Mar 5, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    62
    Registration Numbers
    62
    Same Product Code
    234
    Applicant Total
    8
    Review Days
    84

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    Basic Information

    Device Name
    MD5 AUTOMATIC AUDIOMETER
    K Number
    K896909
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.1050
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Singer Medical Products, Inc.
    Date Received
    December 11, 1989
    Decision Date
    March 5, 1990
    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 Singer Medical Products, Inc.

    K Number Device Name
    K905035 AXOSTIM NERVE STIMULATOR, MODIFICATION
    K894748 IMPEDANCE ANAL/SCREENING AUDIOMETER MD-1 & MD-1P
    K895785 AUDIOMETER MODEL MD-4, MD-4P
    K895783 IMPEDANCE ANALYZER MODELS MD-2, MD-P
    K895784 IMPEDANCE ANALYZER/AUDIOMETER MODEL MD-3
    K896368 MODIFIED AXOSTIM
    K883807 AXOSTIM