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

    SIEMENS SIRECUST TRANSCUTANEOUS CARBON DIOXIDE

    K Number: K891481 · Decision Sep 29, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    16
    Applicant Total
    15
    Review Days
    196

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    Basic Information

    Device Name
    SIEMENS SIRECUST TRANSCUTANEOUS CARBON DIOXIDE
    K Number
    K891481
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.2480
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Siemens Medical Electronics
    Date Received
    March 17, 1989
    Decision Date
    September 29, 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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