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510(k) Data Aggregation

    K Number
    K953175
    Device Name
    AS/3 ESTPR MODULE
    Manufacturer
    DATEX DIVISION INSTRUMENTARIUM CORP.
    Date Cleared
    1997-02-06

    (580 days)

    Product Code
    MLD
    Regulation Number
    870.1025
    Why did this record match?
    Applicant Name (Manufacturer) :

    DATEX DIVISION INSTRUMENTARIUM CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AS/3™ ESTPR module is intended to be used in the Datex AS/3" Anaeshesia Monitor or in the AS/3" Compact Monitor in anesthesia department, in recovery rooms, operation theatres etc.
    Device Description
    The AS/300 ESTPR Module is a part of the modular anesthesia monitoring system AS/300. It provides ECG, SpO2, 2 invasive pressure and 2 temperature channels and impedance respiration measurements. The impedance respiration measurement hardware is in the ESTPR module. The ESTPR Module software measures the respiration signal is sent to the AS/3™ Anaesthesia or Compact Monitor central unit. The AS/3" monitor software receives the respiration signal from the ESTPR module, analyzes the respiration waveform, displays respiration rate and waveform, handles the alarms, trending and other general monitor features. The hardware and software of ECG, SpO2, pleth, invasive pressure and temperature measurements of M-ESTPR are same as in the M-ESTP.
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    K Number
    K961247
    Device Name
    AS/3 LIGHT MONITOR
    Manufacturer
    DATEX DIVISION INSTRUMENTARIUM CORP.
    Date Cleared
    1996-10-23

    (205 days)

    Product Code
    DPS
    Regulation Number
    870.2340
    Why did this record match?
    Applicant Name (Manufacturer) :

    DATEX DIVISION INSTRUMENTARIUM CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AS/3 Light Monitor is intended for stationary and mobile indoor monitoring of a patient's vital signs.
    Device Description
    AS/3 Light Monitor is a portable patient monitor which measures ECG, 2 invasive blood pressures, oxygen saturation SpO2, 2 temperatures and non-invasive blood pressure NIBP. The measurement technics are similar to the AS/3 Compact Monitor with ESTP module and NIBP module. AS/3 Light Monitor will be available in two following configurations: LM which measures ECG, SpO2, 1 temperature and NIBP and LMP which measures ECG, SpO2, 2 invasive blood pressures, 2 temperatures and NIBP. The monitor can be driven with battery or with mains power.
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