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510(k) Data Aggregation

    K Number
    K081823
    Device Name
    MASTERSCREEN PAED - BABY BODY
    Manufacturer
    VIASYS HEALTHCARE GMBH
    Date Cleared
    2009-05-18

    (325 days)

    Product Code
    CCM, BZC
    Regulation Number
    868.1750
    Why did this record match?
    Product Code :

    CCM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MasterScreen Paed - Baby Body is a lung function measurement system for paediatric use. It is intended to be used under the direction of a physician. The MasterScreen Paed - Baby Body may be used in the clinic, doctor's office, or hospital. Patient populations that may benefit from the use of this device include newborns (neonate), infants, children and adolescent. The lung function measurements including RTC and RV-RTC can be performed in term neonates (weight 3kg) up to toddlers (weight 13kg). The digital adult pneumotach with shutter feature is for use with children and adolescent from 4 up to 21 years. The device is AC powered from 115V-240V / 50-60Hz wall outlet.
    Device Description
    MasterScreen Paed - Baby Body is a pediatrics device providing following characteristics: - Mains operation . - Trolley for device and Baby Body box . - Personal Computer System . - Graphic user interface Windows XP Professional . - Powerful database for storing patient- and test data . - Tidal Breathing Analysis . - Baby-Body Plethysmography . - Baby Resistance / Compliance . - Rapid Thoracic Compression (RTC) . - Raised Volume Rapid Thoracic Compression (RV-RTC) . - Spirometry / Flow Volume / MVV for children and adolescents ◆ - Airway Resistance (R Occlusion) for children and adolescents . - P.01 / PImax / PEmax for children and adolescents .
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    K Number
    K023796
    Device Name
    MS PAED-BABY BODY
    Manufacturer
    ERICH JAEGER GMBH
    Date Cleared
    2003-03-03

    (110 days)

    Product Code
    CCM
    Regulation Number
    868.1750
    Why did this record match?
    Product Code :

    CCM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MS PAED - BABY BODY is a neonatal lung function measurement system that utilizes a bodyplethysmograph. It is intended to be used under the direction of a physician. MS PAED - BABY BODY may be used in the clinic, doctors office, or hospital. Patient population that may benefit from the use of this device include only babies and premature infants. The MS PAED – BABY BODY, or any of the accessories supplied with it, is not to be used, alone or in combination, as a life support device, a life support system, or as a critical component in a life support device or life support system.
    Device Description
    The MS PAED - BABY BODY is a local moveable device for the determination of airway resistance, absolute lung volume at FRC and tidal breathing patterns of babies and infants. Equipped with a computer and the Baby-Bodyplethysmography program the software is extremely easy to use, allows you to very quickly make several measurements and tolerates less experienced operators. The operator is to be guided through the program. The built in quality checks of the program prompt the user about a bad performed manoeuvre or an unacceptably low quality of the measurement. The body plethysmography measurement is provided with a reanalysis mode, which means that the physician can modify all data whenever required thereby eliminating the need for patients to return for additional measurements.
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