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

    CO-STAT(TM) END TIDAL BREATH ANALYZER

    K Number: K974805 · Decision Mar 11, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    4
    Applicant Total
    12
    Review Days
    78

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    Basic Information

    Device Name
    CO-STAT(TM) END TIDAL BREATH ANALYZER
    K Number
    K974805
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7425
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Natus Medical, Inc.
    Date Received
    December 23, 1997
    Decision Date
    March 11, 1998
    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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