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

    TRI-MED MODEL 126 SAMPLE LINE W/EXTENDED LIFE NAFI

    K Number: K850746 · Decision Apr 2, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    217
    Registration Numbers
    217
    Same Product Code
    304
    Applicant Total
    29
    Review Days
    36

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    Basic Information

    Device Name
    TRI-MED MODEL 126 SAMPLE LINE W/EXTENDED LIFE NAFI
    K Number
    K850746
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1400
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Tri-Med, Inc.
    Date Received
    February 25, 1985
    Decision Date
    April 2, 1985
    Product Code
    CCK
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

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    Other Clearances by Tri-Med, Inc.

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    K961863 PARACENTESIS TRAYS
    K875224 HUDSON CRANINAL BURRS
    K850747 TRI-MED MODEL 105 SPECIAL AIRWAY ADAPTOR
    K850745 TRI-MED MODEL 112 MOISTURE TRAP
    K843681 RESPIRATION & HEART RATE MONITOR 530
    K843285 TRI-MED 610 CAPNOSTAT GAS ANALYZER
    K842399 48 HOUR SET CHANGES
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