BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇩🇰 Denmark

    VIBRECTOR

    K Number: K851646 · Decision Aug 21, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    25
    Applicant Total
    2
    Review Days
    124

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    Basic Information

    Device Name
    VIBRECTOR
    K Number
    K851646
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    Multicept, Aps.
    Date Received
    April 19, 1985
    Decision Date
    August 21, 1985
    Product Code
    LIL
    Advisory Committee
    Unknown
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LIL Monitor, Penile Tumescence

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    Other Clearances by Multicept, Aps.

    K Number Device Name
    K955589 FERTICARE PERSONAL THERAPEUTIC VIBRATOR