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

    Z-800 VOLUMETRIC INFUSION PUMP

    K Number: K071545 · Decision Oct 31, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    149
    Registration Numbers
    149
    Same Product Code
    847
    Applicant Total
    7
    Review Days
    147

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    Basic Information

    Device Name
    Z-800 VOLUMETRIC INFUSION PUMP
    K Number
    K071545
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Zyno Medical, LLC
    Date Received
    June 6, 2007
    Decision Date
    October 31, 2007
    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

    K Number Device Name
    K153193 Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion System)
    K140783 HALO AMBULATORY INFUSION SYSTEM
    K132841 ZYNO MEDICAL ADMINISTRATION SET
    K130690 Z-800 INFUSION SYSTEM
    K120685 ZYNO MEDICAL ADMINISTRATION SET
    K100705 ZYNO Z-800 INFUSION SYSTEM MODEL Z-800