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

    NEOSHIELD

    K Number: K172499 · Decision Jun 1, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    40
    Registration Numbers
    40
    Same Product Code
    40
    Applicant Total
    9
    Review Days
    287

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    Basic Information

    Device Name
    NEOSHIELD
    K Number
    K172499
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    JMS North America Corporation
    Date Received
    August 18, 2017
    Decision Date
    June 1, 2018
    Product Code
    ONB
    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
    ONB Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System

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