BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent - Subject to Tracking Reg. 🇺🇸 United States

    MODEL 1100 MEDMATE INFUSION PUMP

    K Number: K953270 · Decision Oct 7, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    149
    Registration Numbers
    149
    Same Product Code
    847
    Applicant Total
    5
    Review Days
    86

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    Basic Information

    Device Name
    MODEL 1100 MEDMATE INFUSION PUMP
    K Number
    K953270
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent - Subject to Tracking Reg.
    Applicant
    Patient Solutions, Inc.
    Date Received
    July 13, 1995
    Decision Date
    October 7, 1995
    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 Patient Solutions, Inc.

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