BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇰 Denmark

    MULTI CARE THERAPEUTIC VIBRATOR

    K Number: K010096 · Decision Mar 5, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    3
    Applicant Total
    1
    Review Days
    53

    Basic Information

    Device Name
    MULTI CARE THERAPEUTIC VIBRATOR
    K Number
    K010096
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    884.5960
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Multicept A/S
    Date Received
    January 11, 2001
    Decision Date
    March 5, 2001
    Product Code
    KXQ
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KXQ Vibrator For Therapeutic Use, Genital

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