LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K060835
    Device Name
    HL888SF
    Manufacturer
    HEALTH & LIFE CO., LTD.
    Date Cleared
    2006-04-21

    (25 days)

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

    HL888SF

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

    Measures automatically human's Systolic, Diastolic blood pressure and heart rate by using the oscillornetric method. All values can be read out in one LCD panel. The intended use of this over-the-counter-device is for over the age of 18.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a blood pressure monitor. It does not contain any information regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement.

    Therefore, I cannot provide the requested table and details based on the input document. The document primarily focuses on the regulatory clearance process and states that the device is substantially equivalent to legally marketed predicate devices, meaning it doesn't necessitate new clinical study data for FDA clearance in this instance.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1