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510(k) Data Aggregation

    K Number
    K151024
    Device Name
    Finger Type Pulse Oximeter
    Manufacturer
    TAIDOC TECHNOLOGY CORPORATION
    Date Cleared
    2016-03-02

    (321 days)

    Product Code
    DQA
    Regulation Number
    870.2700
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    k110893
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Finger Type Pulse Oximeter is indicated for use in measuring oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It is intended for patients during no-motion. The patients are limited to adults with weight above 40 kg. This device is indicated for non-invasive spot checking.

    Device Description

    The main function of Finger Type Pulse Oximeter is same as the predicate's to monitor the oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. Except for the general feature, Finger Type Pulse Oximeter also has the wireless data transmission function which transmits the readings of SpO2 and pulse rate from the Finger Type Pulse Oximeter to the personnel device via Bluetooth pairing. The personnel device may include the smart phone, tablet PC and so on.

    AI/ML Overview

    Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    Device MetricAcceptance Criteria (Predicate Device)Reported Device Performance (Proposed Device)
    Accuracy of Oximetry
    70% to 100% SpO2± 2%(Implied) ≤ ± 3% (70-79%) and ≤ ± 2% (80-100%)
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