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510(k) Data Aggregation

    K Number
    K972379
    Device Name
    PRECISA N
    Manufacturer
    RUDOLF RIESTER GMBH & CO. KG
    Date Cleared
    1997-09-24

    (90 days)

    Product Code
    DXQ
    Regulation Number
    870.1120
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PRECISA N

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

    Precisa-N is a sphygmomanometer and is intended to measure the blood pressure (self-meaurement)

    Device Description

    Precisa-N is a sphygmomanometer

    AI/ML Overview

    I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a blood pressure cuff (Precisa-N). It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory information.

    However, this document does not contain any information about:

    • Acceptance criteria or reported device performance in a table.
    • Details of a study (sample size, data provenance, number/qualifications of experts, adjudication method).
    • Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done.
    • Standalone performance (algorithm-only).
    • Type of ground truth used.
    • Training set size or how its ground truth was established.

    Therefore, I cannot fulfill your request based on the provided text.

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