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

    HIGH FREQUENCY AUDIOMETER DELMAR #20-K

    K Number: K803072 · Decision Dec 30, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    62
    Registration Numbers
    62
    Same Product Code
    234
    Applicant Total
    2
    Review Days
    25

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    Basic Information

    Device Name
    HIGH FREQUENCY AUDIOMETER DELMAR #20-K
    K Number
    K803072
    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
    December 5, 1980
    Decision Date
    December 30, 1980
    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
    K841167 DEMLAR SYS I COMPUTER BASED AUDIOMETER