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

    SENDX 100 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM

    K Number: K973742 · Decision Dec 3, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    77
    Registration Numbers
    77
    Same Product Code
    37
    Applicant Total
    6
    Review Days
    63

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    Basic Information

    Device Name
    SENDX 100 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM
    K Number
    K973742
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1170
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sendx Medical, Inc.
    Date Received
    October 1, 1997
    Decision Date
    December 3, 1997
    Product Code
    CGZ
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    CGZ Electrode, Ion-Specific, Chloride

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