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

    DELTEC INSULIN INFUSION PUMP AND ACCESSORIES

    K Number: K020655 · Decision Aug 13, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    83
    Applicant Total
    5
    Review Days
    165

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    Basic Information

    Device Name
    DELTEC INSULIN INFUSION PUMP AND ACCESSORIES
    K Number
    K020655
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Deltec, Inc.
    Date Received
    March 1, 2002
    Decision Date
    August 13, 2002
    Product Code
    LZG
    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
    LZG Pump, Infusion, Insulin

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    Other Clearances by Deltec, Inc.

    K Number Device Name
    K031361 CADD HIGH-VOLUME ADMINISTRATION SETS WITH FLOWSTOP
    K030983 TRUFLOW DUAL-LUMEN POLYURETHANE LONG-TERM STRAIGHT DIALYSIS CATHETER (12.5 FR X 24 CM) WITH TRAY, TRUFLOW DUAL-LUMEN POY
    K022221 TRUFLOW LONG-TERM AND SHORT-TERM DUAL-LUMEN DIALYSIS CATHETERS
    K021999 GRIPPER PLUS NEEDLE