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510(k) Data Aggregation

    K Number
    K970139
    Device Name
    MICROLIFE MANUAL BLOOD PRESSURE MONITOR (MANUAL INFLATE) MODEL BP-2BIO
    Date Cleared
    1998-04-30

    (470 days)

    Product Code
    Regulation Number
    870.2100
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICRO WEISS ELECTRONICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The BP-2BIO Digital Blood Pressure Monitor is a device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm.
    Device Description
    The BP-2BIO Digital Blood Pressure Monitor is designed to measure the systolic and diastolic blood pressure and pulse rate of an individual by using a noninvasive technique which an inflatable cuff is wrapped around the upper arm. Our method to define systolic and diastolic pressures is similar to the auscultatory method but uses an electronic capacitive pressure sensor rather than stethoscope and mercury manometer. The sensor converts tiny alteration in cuff pressure to electrical signals; by analyzing those signals to define the systolic, diastolic and calculating pulse rate is a well known technique in the market so called "oscillometric method".
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    K Number
    K970211
    Device Name
    MICROLIFE AUTOMATIC BLOOD PRESSURE MONITOR
    Date Cleared
    1998-04-30

    (464 days)

    Product Code
    Regulation Number
    870.2100
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICRO WEISS ELECTRONICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The BP-2BHO Digital Blood Pressure Monitor is a device intended to measure the systolic, diastolic and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm.
    Device Description
    The BP-2BHO Digital Blood Pressure Monitor is designed to measure the systolic, diastolic and pulse rate of an individual by using a non-invasive technique which an inflatable curr is wrapper als manufactory of the upper arm. Our technique which an infiatable curr is wrapper als similar to the auscultatory method but uses an electronic capactive sensor rather than stethoscope and mercury manonical. - no onnalyzing those signals to define the cuff pressure to electrical signals, by andryzing the subscripmarket so called "oscillometric method".
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    K Number
    K972259
    Device Name
    PRO CHECK DIGITAL PACIFIER THERMOMETER
    Date Cleared
    1997-07-10

    (23 days)

    Product Code
    Regulation Number
    880.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICRO WEISS ELECTRONICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Pro Check™ Digital Pacifier Thermometer, is a non-sterile, re-usable clinical thermometer intended for the determination of oral body temperature in infants to children five years of age.
    Device Description
    The Pro Check™ Digital Pacifier Thermometer, is a battery-powered, liquid crystal display device using a thermometer embedded in the nipple. The patient contact portion is composed of medical silicone rubber. The body is of ABS plastic. This device is reusable and no components are disposable. This device is not intended for use with other sheaths or devices.
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