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510(k) Data Aggregation

    K Number
    K250854

    Validate with FDA (Live)

    Device Name
    Multi-parameter Patient Monitor (N10); Multi-parameter Patient Monitor (N12); Multi-parameter Patient Monitor (N15); Multi-parameter Patient Monitor (N10MPro); Multi-parameter Patient Monitor (N12MPro); Multi-parameter Patient Monitor (N15MPro)
    Manufacturer
    Shenzhen Comen Medical Instruments Co.,Ltd
    Date Cleared
    2025-12-17

    (271 days)

    Product Code
    MHX
    Regulation Number
    870.1025
    Type
    Traditional
    Panel
    Cardiovascular
    Age Range
    0 - 150
    Reference & Predicate Devices
    K211619,K193242,K123043,K171121,K042601,K103604,K040183,K102084,K231160,K213799
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The N10, N12, N15, N10MPro, N12MPro, NM15Pro Multi-parameter Patient Monitors are intended for monitoring, displaying, reviewing, storing, alarming and transferring of multiple physiological parameters including ECG (3-lead, 5-lead, 12-lead selectable), Arrhythmia Analysis, ST Segment Analysis, QT Analysis, Heart Rate (HR) and Heart-Rate-Variability(HRV)), interpretations of resting 12-lead ECG, Respiration rate(Resp), Temperature(Temp), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), Pulmonary Artery Wedge Pressure (PAWP), Cardiac Output (C.O.), Carbon Dioxide (CO2). The N10MPro, N12MPro, NM15Pro Multi-parameter Patient Monitors are also intended for monitoring, displaying, reviewing, storing, alarming and transferring of physiological parameters including Masimo Rainbow SpO2, Anesthesia gas (AG), oxygen (O2) respiratory gas monitoring, Bispectral Index (BIS), Respiration Mechanics (RM) and Neuromuscular Transmission Monitoring (NMT). All the parameters can be monitored on single adult, pediatric, and neonatal patient except for the following:

    • Arrhythmia analysis is intended to use on adult patients only and is not intended and shall not be used on pediatric and neonatal population.
    • NIBP measurement continual mode is not applicable to neonates.
    • When using COMEN SpO2, the monitor is intended to be used on adult patient only.
    • PAWP is intended for adult and pediatric patients only.
    • C.O. measurement is intended for adult patients only.
    • BIS monitoring is intended for adult patients only.
    • RM is intended for adult and pediatric patients only.
    • NMT monitoring is intended for adult and pediatric patients only.

    The monitors are to be used in healthcare facilities by healthcare professionals or under their guidance.

    The Multi-parameter Patient monitors are not intended for emergency and transport use, aircraft environment or home use.

    The monitors are not intend for use as apnea monitors.

    The monitors are not intended for use in MRI or CT environments.

    The monitors are not used on patients who have a demonstrated need for cardiac monitoring known arrhythmias of VT, Accelerated Idioventricular rhythm and Torsades de Pointes.

    Device Description

    There are six (6) models under evaluation, namely N10, N12, N15, N10MPro, N12MPro, N15MPro. All models share the same intended condition of use, the same intended patient population and operator profile, biological safety characteristic and principle of operation. All these models are the same on electric and electrical circuit and components, mechanical construction, software and alarm system. The only difference lies on the screen and configuration of with/without plug-in module slot and the number of battery packs.

    AI/ML Overview

    N/A

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