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    K Number
    K003943
    Device Name
    MICROGAS 7650 TRANSCUTANEOUS MONITOR
    Manufacturer
    LINDE MEDICAL SENSORS AG
    Date Cleared
    2001-05-04

    (134 days)

    Product Code
    KLK
    Regulation Number
    868.2500
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    Product Code :

    KLK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K991644
    Device Name
    MICROGAS 7650 TRANSCUTANEOUS MONITOR
    Manufacturer
    LINDE MEDICAL SENSORS AG
    Date Cleared
    1999-05-21

    (8 days)

    Product Code
    KLK
    Regulation Number
    868.2500
    Why did this record match?
    Product Code :

    KLK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Linde Transcutaneous Monitor is intended to measure the partial pressure of oxygen and carbon dioxide that passes through the cutaneous layer of the skin of an infant who is not under gas anesthesia by a sensor attached to the surface of the infant's skin.
    Device Description
    Detailed description of the device is contained in the MicroGas 7650 Operator's Manual located in Appendix 2 of this document.
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    K Number
    K980287
    Device Name
    SIEMENS SC9000/SC9015 TCP02/C02 MODULE
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Date Cleared
    1998-08-12

    (198 days)

    Product Code
    KLK
    Regulation Number
    868.2500
    Why did this record match?
    Product Code :

    KLK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Siemens Transcutaneous tpO2/CO2 Gas Module is indicated for use to continuously monitor the noninvasive trending of transcutaneous oxygen in the neonatal population when the patient is not under gas anesthesia. Siemens Transcutaneous tp02/CO2 Gas Module is indicated for use to continuously monitor the noninvasive trending of transcutaneous carbon dioxide partial pressure in any patient population. The device is indicated for use in an environment where patient care is provided by healthcare professionals, i.e. Physicians, Nurses, Technicians, when the professional determines that the device is required.
    Device Description
    The Transcutaneous Gas Module (tpO/CO2 pod) is an addition to Siemens SC9000 patient monitoring series which provides transcutaneous measurement of partial pressures of the 02 and CO2 in the peripheral tissue of a patient.
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    K Number
    K924709
    Device Name
    SATCARE OXYGEN CONTROLLER/MONITOR W/ PULSE OXIMETE
    Manufacturer
    AIR-SHIELDS, INC.
    Date Cleared
    1996-01-17

    (1216 days)

    Product Code
    KLK
    Regulation Number
    868.2500
    Why did this record match?
    Product Code :

    KLK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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