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

    AUTOMATED MULTI-POINT BLOOD VOLUME ANALYZER

    K Number: K964406 · Decision Sep 25, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    0
    Applicant Total
    2
    Review Days
    325

    Basic Information

    Device Name
    AUTOMATED MULTI-POINT BLOOD VOLUME ANALYZER
    K Number
    K964406
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5950
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    DAXOR CORPORATION
    Date Received
    November 4, 1996
    Decision Date
    September 25, 1997
    Product Code
    JWO
    Advisory Committee
    Hematology
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JWO Device, Blood Volume Measuring

    Other Clearances by DAXOR CORPORATION

    K Number Device Name
    K970419 DAXOR MAX100 SYRINGE (MAX100)