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

    BIOREM 3000 & 4000

    K Number: K833454 · Decision Feb 21, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    25
    Applicant Total
    2
    Review Days
    146

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    Basic Information

    Device Name
    BIOREM 3000 & 4000
    K Number
    K833454
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    Biorem
    Date Received
    September 28, 1983
    Decision Date
    February 21, 1984
    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 Biorem

    K Number Device Name
    K822099 BIOREM 2000