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    K Number
    K040380
    Device Name
    DOLPHIN MEDICAL DOLPHIN ONE ADULT REUSABLE FOREHEAD SENSOR, MODEL 420
    Manufacturer
    DOLPHIN MEDICAL INC.
    Date Cleared
    2004-08-31

    (196 days)

    Product Code
    DQA
    Regulation Number
    870.2700
    Type
    Special
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K030629
    Why did this record match?
    Device Name :

    DOLPHIN MEDICAL DOLPHIN ONE ADULT REUSABLE FOREHEAD SENSOR, MODEL 420

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

    The Dolphin ONE Oximetry Sensors are indicated for use in continuous monitoring of arterial oxygen saturation and pulse rate.

    The Dolphin ONE Model 420 oximetry sensor is indicated for continuous noninvasive monitoring of arterial oxygen saturation and pulse rate.

    Device Description

    The Dolphin ONE Forehead Oximetry Sensor is a reusable sensor for use with approved Dolphin ONE pulse oximeter monitors.

    The reusable forehead sensor is for use on the forehead and held in place with a disposable adhesive disc and headband. The emitter and detector are mounted in a sealed pouch (same materials as in the reusable Y sensor above) constructed in a flat cylindrical shape. The sensor is provided non-sterile.

    AI/ML Overview

    Here's an analysis of the provided text regarding the acceptance criteria and study for the Dolphin ONE Pulse Oximetry Forehead Sensor:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance CriterionReported Device Performance
    Accuracy (ARMS)
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