BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇭 Switzerland

    Sentec Digital Monitoring System (SDMS) tCOM+

    K Number: K232516 · Decision May 17, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    16
    Applicant Total
    5
    Review Days
    273

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    Basic Information

    Device Name
    Sentec Digital Monitoring System (SDMS) tCOM+
    K Number
    K232516
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.2480
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sentec AG
    Date Received
    August 18, 2023
    Decision Date
    May 17, 2024
    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 Sentec AG

    K Number Device Name
    K243765 LuMon(TM) System
    K151329 SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC Software including V-CareNet
    K101690 SENTEC DIGITAL MONITOR, V-SIGN SENSOR AND V-SIGN SENSOR 2 WITH DIGITAL SENSOR ADAPER CABLE
    K071672 SENTEC DIGITAL MONITORING SYSTEM