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

    MTP TRANSPORT INFUSION PUMP, MODEL NO. MTPLEA

    K Number: K910335 · Decision Mar 13, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    149
    Registration Numbers
    149
    Same Product Code
    847
    Applicant Total
    8
    Review Days
    47

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    Basic Information

    Device Name
    MTP TRANSPORT INFUSION PUMP, MODEL NO. MTPLEA
    K Number
    K910335
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Medical Technical Products
    Date Received
    January 25, 1991
    Decision Date
    March 13, 1991
    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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    K904612 I/A-PHACO SYSTEM (IRR./ASPIR./AND PHACO./SYSTEM)
    K871474 PART #860070 ULTRAPAK & #860075 ULTRAPAK
    K871473 PART #860065 IA PAK & PART #860060 IA PAK