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

    MEDFUSION 2001 & 2010, MODEL N7215IWC

    K Number: K012259 · Decision Sep 12, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    37
    Registration Numbers
    37
    Same Product Code
    47
    Applicant Total
    12
    Review Days
    56

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    Basic Information

    Device Name
    MEDFUSION 2001 & 2010, MODEL N7215IWC
    K Number
    K012259
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    National Custom Ent., Inc.
    Date Received
    July 18, 2001
    Decision Date
    September 12, 2001
    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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    K941995 NCE REPLACEMENT BATTERIES
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