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510(k) Data Aggregation

    K Number
    K990293
    Device Name
    ALADDIN II MONITORING OXYGEN/AIR MONITOR
    Manufacturer
    HAMILTON MEDICAL, INC.
    Date Cleared
    1999-03-16

    (46 days)

    Product Code
    BZR
    Regulation Number
    868.5330
    Type
    Special
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ALADDIN II MONITORING OXYGEN/AIR MONITOR

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

    Aladdin Monitoring Oxygen/Air Mixer is intended to mix and air and oxygen gases and provide the mixed gas at the prescribed oxygen concentration level via flowmeter (1 to 10 LPM). the device is intended for use within the hospital or institutional environment.

    Device Description

    Aladdin Monitoring Oxygen/Air Mixer is intended to mix and air and oxygen gases and provide the mixed gas at the prescribed oxygen concentration level via flowmeter (1 to 10 LPM).

    AI/ML Overview

    This document is a 510(k) premarket notification letter from the FDA to Hamilton Medical, Inc. for the Aladdin II Monitoring Oxygen/Air Mixer. It primarily discusses the regulatory classification and marketing authorization for the device. It does not contain information about acceptance criteria or a study proving the device meets those criteria, nor does it include details about device performance, sample sizes, ground truth establishment, or expert reviews as requested in the prompt.

    Therefore, I cannot provide the requested information based on the given text. The text does not describe a study or device performance data.

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