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510(k) Data Aggregation

    K Number
    K031860
    Device Name
    SK MED ME202 MONITORING MIXER
    Manufacturer
    SK MED
    Date Cleared
    2004-01-21

    (219 days)

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

    SK MED ME202 MONITORING MIXER

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

    The M202 Monitoring Mixer is intended to mix air and oxygen gases and provide the mixed gas at the prescribed oxygen concentration level via flowmcter (1 to 12 I.PM). The device is a prescription device and is intended for use within the hospital or institutional environment.

    Device Description

    SK Med M202 Mixer

    AI/ML Overview

    This is an FDA premarket notification (510(k)) letter for the SK Med M202 Mixer. While it confirms clearance for the device, it does not contain the information requested about acceptance criteria and a study proving device performance.

    The document primarily states that the device is "substantially equivalent" to legally marketed predicate devices and is thus cleared for marketing. It outlines regulatory requirements and general information but does not include:

    • A table of acceptance criteria or reported device performance.
    • Details about a study (sample size, data provenance, ground truth, expert qualifications, adjudication methods, etc.).
    • Information on MRMC comparative effectiveness or standalone algorithm performance.
    • Training set details.

    Therefore, I cannot provide the requested information from this document.

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