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

    DEMLAR SYS I COMPUTER BASED AUDIOMETER

    K Number: K841167 · Decision Jun 27, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    62
    Registration Numbers
    62
    Same Product Code
    234
    Applicant Total
    2
    Review Days
    100

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    Basic Information

    Device Name
    DEMLAR SYS I COMPUTER BASED AUDIOMETER
    K Number
    K841167
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.1050
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Demlar Medical, Inc.
    Date Received
    March 19, 1984
    Decision Date
    June 27, 1984
    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 Demlar Medical, Inc.

    K Number Device Name
    K803072 HIGH FREQUENCY AUDIOMETER DELMAR #20-K