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510(k) Data Aggregation

    K Number
    K022864
    Device Name
    SK MED M201 MIXER
    Manufacturer
    SK MED
    Date Cleared
    2003-04-11

    (226 days)

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

    SK MED M201 MIXER

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

    The M201 Mixer is used to deliver a mixture of air and oxygen in conjunction with oxygen hoods, resuscitation bags, masks, and nasal cannulas. The user can adjust the oxygen percentage within a range of 21-100% and the flow rate within a range of 0-30 liters per minute. Additionally, the device monitors the air supply pressure, oxygen supply pressure, battery voltage, and output oxygen percentage.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device called the "SK Med M201 Mixer." It is concerned with the regulatory approval of the device and does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

    Therefore, I cannot provide the requested information based on the provided text. The document focuses on confirming that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory responsibilities, not on the technical performance study details.

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