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510(k) Data Aggregation

    K Number
    K981805
    Device Name
    POS T-7000
    Manufacturer
    POS TECHNOLOGIES, INC.
    Date Cleared
    1998-08-07

    (78 days)

    Product Code
    HCS
    Regulation Number
    882.1570
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    POS TECHNOLOGIES, INC.

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

    To measure bilateral differences in skin temperature along the spine

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but after reviewing the provided documents, I could not find information about specific acceptance criteria, study details, or device performance that would allow me to answer your request. The documents are a clearance letter from the FDA for a device called "POS T-7000," indicating it is substantially equivalent to legally marketed predicate devices, along with its indications for use. They do not contain scientific study results, sample sizes, expert qualifications, or ground truth establishment methods.

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