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

    DENTAL ANESTHESIA APPARATUS

    K Number: K850425 · Decision Oct 9, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    18
    Applicant Total
    1
    Review Days
    612

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    Basic Information

    Device Name
    DENTAL ANESTHESIA APPARATUS
    K Number
    K850425
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.1375
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Pain Prevention, Inc.
    Date Received
    February 4, 1985
    Decision Date
    October 9, 1986
    Product Code
    KZM
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KZM Device, Muscle Monitoring

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