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

    PANOJECT MINIFUSOR MODEL 200 AMBU. INFUSION PUMP

    K Number: K930495 · Decision Apr 26, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    149
    Registration Numbers
    149
    Same Product Code
    847
    Applicant Total
    2
    Review Days
    449

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    Basic Information

    Device Name
    PANOJECT MINIFUSOR MODEL 200 AMBU. INFUSION PUMP
    K Number
    K930495
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Elan Medical Technologies, Ltd.
    Date Received
    February 1, 1993
    Decision Date
    April 26, 1994
    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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    Other Clearances by Elan Medical Technologies, Ltd.

    K Number Device Name
    K930494 PANOJECT MINIFUSOR MODEL 100 AMBULATORY INFUSION