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    K Number
    K032947
    Device Name
    NELLCOR COMPATIBLE DOLPHIN 2000 Y OXIMETRY SENSOR, MODEL 2210
    Manufacturer
    DOLPHIN MEDICAL INC.
    Date Cleared
    2003-10-17

    (25 days)

    Product Code
    DQA
    Regulation Number
    870.2700
    Type
    Special
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K030952,K991823
    Why did this record match?
    Device Name :

    NELLCOR COMPATIBLE DOLPHIN 2000 Y OXIMETRY SENSOR, MODEL 2210

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

    The Dolphin 2000 Oximetry Sensors are indicated for use in continuous monitoring of arterial oxygen saturation and pulse rate.

    Device Description

    The Dolphin 2000 Y Oximetry Sensor is a fully compatible re-usable replacement sensor for use with Nellcor pulse oximeter monitors. The Re-usable Y sensor is for use on the ear, finger, hand, or neonatal foot and held in place with a disposable bandage. The sensor can also be used on the adult ear with the ear clip accessory. The emitter and detector are mounted in a sealed pouch (same material as in the re-usable clip sensor above) constructed in a Y shape. The sensor is provided non-sterile.

    AI/ML Overview

    Here's a summary of the acceptance criteria and study details for the Dolphin 2000™ Pulse Oximetry Y Sensor, based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    ParameterAcceptance Criteria (Implied)Reported Device Performance (Accuracy)
    SpO2 Accuracy (Adults, Pediatrics, Infants)Less than 2.0% ARMs (Absolute Root Mean Square difference)
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