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

    NOVAMETRIX 811 TRANSCO2M PORTABLE TRANSCUTANEOUS 2

    K Number: K844253 · Decision Jan 10, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    46
    Applicant Total
    45
    Review Days
    69

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    Basic Information

    Device Name
    NOVAMETRIX 811 TRANSCO2M PORTABLE TRANSCUTANEOUS 2
    K Number
    K844253
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.2500
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Novametrix Medical Systems, Inc.
    Date Received
    November 2, 1984
    Decision Date
    January 10, 1985
    Product Code
    KLK
    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
    KLK Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia

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