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510(k) Data Aggregation

    K Number
    K011310
    Device Name
    NIEN MADE NON-INVASIVE BLOOD PRESSURE MONITOR, MODELS HP-BPM0001; HP-BPM0002; HP-BPM0003; HP-BPM0003-1
    Manufacturer
    NIEN MADE ELECTRNICS CORP.
    Date Cleared
    2001-07-20

    (81 days)

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

    NIEN MADE ELECTRNICS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K993950
    Device Name
    CECILIA PENGUIN MULTI-USE THERMOMETER, MODEL HP-ETO9999
    Manufacturer
    NIEN MADE ELECTRNICS CORP.
    Date Cleared
    2000-08-23

    (275 days)

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

    NIEN MADE ELECTRNICS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    For intermittent measurement of body temperature in patients of all ages in the home environment by measurement of infrared radiation emitted, solely, from the tympanic membrane.
    Device Description
    The Cecilia® Thermometer consists of an IR sensor, an electronic signal processing detector, a digital LCD display, and disposable probe covers.
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