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510(k) Data Aggregation

    K Number
    K031707
    Device Name
    SK MED M201 PLUS MIXER
    Manufacturer
    SK MED
    Date Cleared
    2003-08-01

    (60 days)

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

    SK MED M201 PLUS MIXER

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

    The M201Plus 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

    I am sorry, but based on the provided text, there is no information about acceptance criteria, a study that proves a device meets acceptance criteria, sample sizes, data provenance, ground truth establishment, or any information related to AI or multi-reader multi-case studies.

    The document is a 510(k) premarket notification letter from the FDA to SK Med, Incorporated, concerning their SK Med M201 Plus Mixer, classified as a Breathing Gas Mixer. It primarily discusses the substantial equivalence determination of the device and regulatory compliance requirements.

    Therefore, I cannot provide the requested table and information.

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