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

    CHARTER MEDICAL NEONATAL SYRINGE SET

    K Number: K000685 · Decision Aug 15, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    29
    Applicant Total
    2
    Review Days
    168

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    Basic Information

    Device Name
    CHARTER MEDICAL NEONATAL SYRINGE SET
    K Number
    K000685
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Charter Medical, Ltd.
    Date Received
    February 29, 2000
    Decision Date
    August 15, 2000
    Product Code
    BRZ
    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
    BRZ Set, Blood Transfusion

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