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

    SERVOMED OXYMONITO SMK 363

    K Number: K842497 · Decision Oct 4, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    46
    Applicant Total
    5
    Review Days
    100

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    Basic Information

    Device Name
    SERVOMED OXYMONITO SMK 363
    K Number
    K842497
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.2500
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Litton Datamedix
    Date Received
    June 26, 1984
    Decision Date
    October 4, 1984
    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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    Other Clearances by Litton Datamedix

    K Number Device Name
    K853599 LITTON DATAMEDIX BLOOD PRESSURE MONITOR NI
    K850290 ULTRASOUND GEL
    K842235 SERVOCARD DEFIBRILLATOR SCP-851
    K842312 SERVOCARD SCP-840