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510(k) Data Aggregation

    K Number
    K050413
    Device Name
    AMPLIEF WRIST BLOOD PRESSURE MONITOR, MODEL M600
    Manufacturer
    AMPLIFE CORPORATION
    Date Cleared
    2005-03-04

    (14 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMPLIFE CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AMPLIFE Wrist Watch Blood Pressure Monitor, Model M600 is a device intended to measure the systolic and diastolic blood pressure and pulse rate of intendou to ividual by using a non-invasive technique in which an inflatable cuff is wrapped around the Wrist.
    Device Description
    The AMPLIFE Wrist Watch Automatic Blood Pressure Monitor, Model M600 is designed to measure the systolic and diastolic blood pressure and pulse rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the Wrist. Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic semiconductor sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well known technique in the market called the "oscillometric method".
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    K Number
    K043550
    Device Name
    AMPLIFE UPPER ARM BLOOD PRESSURE MONITOR, MODEL M100
    Manufacturer
    AMPLIFE CORPORATION
    Date Cleared
    2005-01-27

    (35 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMPLIFE CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AMPLIFE Upper Arm Blood Pressure Monitor, Model M100, 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 AMPLIFE Upper Arm Automatic Blood Pressure Monitor, Model M100 is designed to measure the systolic and diastolic blood pressure and pulse rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the Upper arm. Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic semiconductor sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well - known technique in the market called the "oscillometric method".
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    K Number
    K042906
    Device Name
    AMPLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL E101
    Manufacturer
    AMPLIFE CORPORATION
    Date Cleared
    2004-11-19

    (29 days)

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

    AMPLIFE CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AMPLIFE Digital Infrared Ear Thermometer, Model E100, is a Digital Infrared Ear Thermometer (without probe cover) using an infrared sensor to detect body temperature from the ear in the neonatal, pediatric and adult population used in the home setting. The device is used without a probe cover.
    Device Description
    The AMPLIFE Digital Infrared Ear Thermometer, Model E100 is a digital infrared Ear Thermometer (without probe cover) using an infrared sensor (thermopile) to measure eardrum temperature, then get a reading and display it on the LCD. Its operation is based on measuring the natural thermal radiation emanating from the eardrum. The AMPLIFE Digital Infrared Ear Thermometer, consists mainly of five parts: - a) IR Thermopile Sensor - b) ASIC c) E2PROM IC d) LCD and Blacklight - e) Kev*2, Buzzer*1
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    K Number
    K042575
    Device Name
    AMPLIFE DIGITAL CLINICAL THERMOMETER
    Manufacturer
    AMPLIFE CORPORATION
    Date Cleared
    2004-09-30

    (8 days)

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

    AMPLIFE CORPORATION

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