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

    TRANSCUTANEOUS O2/CO2 MONITOR

    K Number: K890517 · Decision Apr 14, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    16
    Applicant Total
    45
    Review Days
    74

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    Basic Information

    Device Name
    TRANSCUTANEOUS O2/CO2 MONITOR
    K Number
    K890517
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.2480
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Novametrix Medical Systems, Inc.
    Date Received
    January 30, 1989
    Decision Date
    April 14, 1989
    Product Code
    LKD
    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
    LKD Monitor, Carbon-Dioxide, Cutaneous

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    Other Clearances by Novametrix Medical Systems, Inc.

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    K963380 CO 2 SMO PLUS
    K963327 TIDAL WAVE CARBON DIOXIDE MONITOR, MODEL 610
    K960831 VENTRAK RMMS 1550
    K924626 NOVAMETRIX MODEL 510
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