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510(k) Data Aggregation

    K Number
    K983616
    Device Name
    DAIWA MODEL 180
    Manufacturer
    DAIWA PRODUCTS, INC.
    Date Cleared
    1999-10-15

    (366 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Daiwa Model 180 Automatic Inflation Wrist Digital Blood Pressure Monitor is designed to provide signals from which systolic and diastolic pressures can be derived through the use of the oscillometric method. The device also measures the heart rate. The device is for adult use only and measures wrist circumferences from 5 1/4" to 7 3/4". The end user should not have common arrhythmias, such as atrial or ventricular premature beats or atrial fibrillation

    Device Description

    Automatic Inflation Wrist Digital Blood Pressure Monitors

    AI/ML Overview

    This document is a 510(k) clearance letter for the Daiwa Model 180 Automatic Inflation Wrist Digital Blood Pressure Monitor, issued by the FDA in 1999. It does not contain the detailed study information, acceptance criteria, or performance data typically found in a clinical study report or a more comprehensive summary of safety and effectiveness.

    Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for the device from the provided text.

    The document primarily focuses on the regulatory clearance process, stating that the device is "substantially equivalent" to legally marketed predicate devices and outlining general regulatory requirements.

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