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

    ZYNO Z-800 INFUSION SYSTEM MODEL Z-800

    K Number: K100705 · Decision Jul 8, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    149
    Registration Numbers
    149
    Same Product Code
    847
    Applicant Total
    7
    Review Days
    118

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    Basic Information

    Device Name
    ZYNO Z-800 INFUSION SYSTEM MODEL Z-800
    K Number
    K100705
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Zyno Medical, LLC
    Date Received
    March 12, 2010
    Decision Date
    July 8, 2010
    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 Zyno Medical, LLC

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