BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    INFUTEST 2000 INFUSION DEVICE ANALYZER

    K Number: K980165 · Decision Apr 20, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    37
    Registration Numbers
    37
    Same Product Code
    47
    Applicant Total
    2
    Review Days
    94

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    Basic Information

    Device Name
    INFUTEST 2000 INFUSION DEVICE ANALYZER
    K Number
    K980165
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Datrend Systems, Inc.
    Date Received
    January 16, 1998
    Decision Date
    April 20, 1998
    Product Code
    MRZ
    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
    MRZ Accessories, Pump, Infusion

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    Other Clearances by Datrend Systems, Inc.

    K Number Device Name
    K062099 PHASE 3, MODEL DT-1