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510(k) Data Aggregation

    K Number
    K221486
    Device Name
    INDEX BPM
    Manufacturer
    Ya Horng Electronic Co., Ltd.
    Date Cleared
    2022-08-30

    (99 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    INDEX BPM

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

    The INDEX™ BPM device is a tubeless blood pressure monitor. This is a medical device intended to measure systolic and diastolic blood pressure and pulse rate.

    Device Description

    The INDEX™ BPM device is a tubeless blood pressure monitor.

    AI/ML Overview

    I am sorry, but the provided documentation does not contain information about the acceptance criteria or any study details that prove the device meets these criteria. The document is an FDA 510(k) clearance letter and an "Indications for Use" statement, which primarily focuses on the regulatory aspects of the device, its intended use, and substantial equivalence to a predicate device, rather than detailed performance study results.

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