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

    BETAFLO 2000

    K Number: K862273 · Decision Jul 18, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    59
    Applicant Total
    2
    Review Days
    32

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    Basic Information

    Device Name
    BETAFLO 2000
    K Number
    K862273
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Betaflo, Inc.
    Date Received
    June 16, 1986
    Decision Date
    July 18, 1986
    Product Code
    LDR
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LDR Controller, Infusion, Intravascular, Electronic

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    Other Clearances by Betaflo, Inc.

    K Number Device Name
    K864789 BETAFLO 2000 PIGGYBACK SYSTEM