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

    HBO CABLE ASSEMBLY, RADIOMETER TC-02

    K Number: K905225 · Decision Apr 10, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    16
    Applicant Total
    2
    Review Days
    141

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    Basic Information

    Device Name
    HBO CABLE ASSEMBLY, RADIOMETER TC-02
    K Number
    K905225
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.2480
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Sechrist
    Date Received
    November 20, 1990
    Decision Date
    April 10, 1991
    Product Code
    LKD
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    RA
    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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