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

    CADD-1, MODEL 5100 HF

    K Number: K862927 · Decision Aug 27, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    149
    Registration Numbers
    149
    Same Product Code
    847
    Applicant Total
    9
    Review Days
    26

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    Basic Information

    Device Name
    CADD-1, MODEL 5100 HF
    K Number
    K862927
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Deltec Systems, Inc.
    Date Received
    August 1, 1986
    Decision Date
    August 27, 1986
    Product Code
    FRN
    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
    FRN Pump, Infusion

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    K850183 CADD-VT, 5300 AMBULATORY INFUSION PUMP W/3050, 50M
    K843772 CADD-1 5100 AMBULATORY INFUSION PUMP
    K843773 CADD-PAC 5200 AMBULATORY INFUSION PUMP
    K833949 MICRO INFUSION SET