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

    MODEL HP 15209A TRANS. COMBINED TCP02/TCPCO2 TRANS

    K Number: K883606 · Decision Dec 16, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    16
    Applicant Total
    230
    Review Days
    115

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    Basic Information

    Device Name
    MODEL HP 15209A TRANS. COMBINED TCP02/TCPCO2 TRANS
    K Number
    K883606
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.2480
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Hewlett-Packard Co.
    Date Received
    August 23, 1988
    Decision Date
    December 16, 1988
    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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