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

    MICROGAS 7650 TRANSCUTANEOUS MONITOR

    K Number: K991644 · Decision May 21, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    46
    Applicant Total
    4
    Review Days
    8

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    Basic Information

    Device Name
    MICROGAS 7650 TRANSCUTANEOUS MONITOR
    K Number
    K991644
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    868.2500
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Linde Medical Sensors AG
    Date Received
    May 13, 1999
    Decision Date
    May 21, 1999
    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 Linde Medical Sensors AG

    K Number Device Name
    K043357 TOSCA 500 PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM, MODEL 5202009
    K032291 TOSCA PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM
    K003943 MICROGAS 7650 TRANSCUTANEOUS MONITOR