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510(k) Data Aggregation

    K Number
    K952315
    Device Name
    SATMASTER, COMPUTERIZED PULSE OXIMETRY SOFTWARE
    Manufacturer
    Date Cleared
    1996-12-04

    (567 days)

    Product Code
    Regulation Number
    870.2700
    Why did this record match?
    Applicant Name (Manufacturer) :

    EMG SCIENTIFIC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Sathlaster is intended for use an adjunct to traditional Pulse Oximetry, in which the caregiver observes instantaneous Pulse Oximetry values as displayed on a Pulse Oximeter's face. SatMaster produces graphs and statistics describing a patient's Pulse Oximerry data trends over relatively long periods of time, including those times when the caregiver is not directly observing the Pulse Oximeter's display.
    Device Description
    SatMaster is the name of EMG Scientific's Computerized Pulse Oximetry Software product. This product consists of a Program Diskette, a Software License, a User Manual, and a Test Cable. Thus, SatMaster is a software-only "device," intended for use with an MS-DOS, PC-type computer provided by the end-user. Briefly, the SatMaster software provides a PC computer user the capability of transferring Pulse Oximetry data from a Pulse Oximeter, storing the data on the computer, displaying the data in various forms, annotating the data, calculating statistics, and printing the results.
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