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

    CHARTER MEDICAL, LTD MP 450 (40 MICRON FILTER)

    K Number: K990310 · Decision Aug 30, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    35
    Applicant Total
    2
    Review Days
    210

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    Basic Information

    Device Name
    CHARTER MEDICAL, LTD MP 450 (40 MICRON FILTER)
    K Number
    K990310
    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 1, 1999
    Decision Date
    August 30, 1999
    Product Code
    CAK
    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
    CAK Microfilter, Blood Transfusion

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    Other Clearances by Charter Medical, Ltd.

    K Number Device Name
    K000685 CHARTER MEDICAL NEONATAL SYRINGE SET