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510(k) Data Aggregation

    K Number
    K984506
    Device Name
    SD-100 SKYEAR THERMOMETER
    Manufacturer
    SKYLARK DEVICE CO., LTD.
    Date Cleared
    1999-07-29

    (223 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SD-100 SKYEAR THERMOMETER

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The SD-100 SKYEAR THERMOMETER is designed for file 3D 100 -

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets those criteria. The document is an FDA letter to a device manufacturer, confirming the substantial equivalence of the "SD-100 Skyear Thermometer" to legally marketed predicate devices. It discusses regulatory matters, such as the classification of the device, applicable regulations, and marketing permissions, but it does not detail performance acceptance criteria or study results.

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