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

    ERYPUR B

    K Number: K864636 · Decision Jan 14, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    35
    Applicant Total
    130
    Review Days
    49

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    Basic Information

    Device Name
    ERYPUR B
    K Number
    K864636
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Organon Teknika Corp.
    Date Received
    November 26, 1986
    Decision Date
    January 14, 1987
    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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