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

    ECOLYZER CARBOXIMETER

    K Number: K770209 · Decision Mar 7, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    4
    Applicant Total
    1
    Review Days
    35

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    Basic Information

    Device Name
    ECOLYZER CARBOXIMETER
    K Number
    K770209
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7425
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Iadec, Inc.
    Date Received
    January 31, 1977
    Decision Date
    March 7, 1977
    Product Code
    GHS
    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
    GHS Assay, Carboxyhemoglobin

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