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

    TOSCA PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM

    K Number: K032291 · Decision Aug 24, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    0
    Applicant Total
    4
    Review Days
    397

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    Basic Information

    Device Name
    TOSCA PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM
    K Number
    K032291
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3320
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Linde Medical Sensors AG
    Date Received
    July 24, 2003
    Decision Date
    August 24, 2004
    Product Code
    DOA
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DOA Radioimmunoassay, Digoxin (125-I), Goat Antibody, Anion Exchange, Resin Sep.

    Other Clearances by Linde Medical Sensors AG

    K Number Device Name
    K043357 TOSCA 500 PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM, MODEL 5202009
    K003943 MICROGAS 7650 TRANSCUTANEOUS MONITOR
    K991644 MICROGAS 7650 TRANSCUTANEOUS MONITOR