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510(k) Data Aggregation

    K Number
    K221879
    Device Name
    Patient Monitor, models LM-8, LM-10, LM-12 and LM-15
    Manufacturer
    CAF Medical Solutions Inc.
    Date Cleared
    2022-08-10

    (43 days)

    Product Code
    MHX, BZK, BZQ, CBQ, CBR, CBS, CCK, CCL, DPS, DQA, DRG, DRT, DSB, DSK, DST, DXN, FLL, MLD, NHO, NHP, NHQ
    Regulation Number
    870.1025
    Why did this record match?
    Applicant Name (Manufacturer) :

    CAF Medical Solutions Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The monitors are intended to be used for monitoring, storing, and to generate alarms for, multiple physiological parameters of adults and pediatrics. The monitors are intended for use by trained healthcare professionals in hospital environments. The LM-8 monitor monitors parameters such as ECG (3-lead, 12-lead selectable), Respiration (RESP), Functional arterial oxygen saturation (SpO2), Invasive or noninvasive blood pressure (dual-IBP, NIBP), Temperature (dual-TEMP), Expired CO2 and Quick Temperature (Quick TEMP). The LM-10 monitor monitors parameters such as ECG (3-lead, 12-lead selectable), Respiration (RESP), Functional arterial oxygen saturation (SpO2), Invasive or noninvasive blood pressure (2/4 channels IBP, NIBP), Cardiac Output (C.O.), Temperature (dual-TEMP) and Expired CO2. The LM-12 monitor monitors parameters such as ECG (3-lead, 12-lead selectable), Respiration (RESP), Functional arterial oxygen saturation (SpO2), Invasive or noninvasive blood pressure (2/4 chamels IBP, NIBP), Cardiac Output (C.O.), Temperature (dual-TEMP), Expired CO2 and Anesthetic gas (AG). The LM-15 monitors parameters such as ECG (3-lead, 5-lead, 12-lead selectable), Respiration (RESP), Functional arterial oxygen saturation (SpO2), Invasive or noninvasive blood pressure (2/4 channels IBP, NIBP), Cardiac Output (C.O.), Temperature (dual-TEMP), Expired CO2 and Anesthetic gas (AG). The arrhythmia detection and ST Segment analysis are intended for adult and pediatric patients. The monitors are not intended for MRI environments.
    Device Description
    LM-8, LM-10, LM-12 and LM-15, patient monitor integrates parameter measuring modules, display and recorder in one device, featuring in compactness, lightweight and portability. Replaceable built-in battery facilitates patient transport. Large high-resolution display provides clear view of 10 waveforms and full monitoring parameters. Patient Monitor can monitor vital signal such as ECG, respiration (RESP), non-invasive blood pressure (NIBP), oxygen saturation of the blood (SpO2), temperature (TEMP), invasive blood pressure (IBP), cardiac output (C.O.), CO2 and anesthetic gas (AG). Those signals are digitized, processed and examined for alarm conditions, after that presents all those information on the color TFT display. The monitor also provides advantageous operating control for the user.
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    K Number
    K221616
    Device Name
    Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17
    Manufacturer
    CAF Medical Solutions Inc.
    Date Cleared
    2022-08-01

    (59 days)

    Product Code
    MHX, BZK, BZQ, CBQ, CBR, CBS, CCK, CCL, DPS, DQA, DRG, DRT, DSB, DSK, DST, DXN, FLL, MLD, NHO, NHP, NHQ
    Regulation Number
    870.1025
    Why did this record match?
    Applicant Name (Manufacturer) :

    CAF Medical Solutions Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The monitors are intended to be used for monitoring, storing, and to generate alarms for, multiple physiological parameters of adults, pediatrics and neonates. The monitors are intended for use by trained healthcare professionals in hospital environments. The monitored physiological parameters include: ECG, respiration (RESP), temperature (TEMP), oxygen saturation of arterial blood (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), carbon dioxide (CO2), cardiac output (C.O.), anesthetic gas (AG), bispectral index (BIS), respiration mechanice cardiography (ICG). BIS is intended for use on adult and pediatric patients. ICG monitoring is intended for use on adults only. The arrhythmia detection and ST Segment analysis are intended for adult patients. The monitors are additionally intended for use during patient transport inside hospitals. The monitors are not intended for MRI environments.
    Device Description
    LMPLUS series Patient Monitor including LMPLUS-12, LMPLUS-15 and LMPLUS-17 which can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormity so that doctors and nurses can deal with them in time. The LMPLUS series Patient Monitor realize the monitoring of physiological parameters by configuration with different parameter modules which include SpO2 (pulse oxygen saturation, pulse rate and SpO2 plethysmogram) with EDAN SpO2 module or Nellcor SPO2 module, NIBP (systolic pressure, diastolic pressure and pulse rate), TEMP, ECG, RESP (respiration), CO2, IBP, C.O. and AG (anesthetic gas), RM (respiratory mechanics), BIS (bispectral index) and ICG (impedance cardiography). The above is the maximum configuration for LMPLUS series Patient Monitor, the user may select different monitoring parameters in according with their requirements. LMPLUS-12 configures with 12.1-inch color TFT touch screen, LMPLUS-15 and LMPLUS-17 with same screen except different sizes 15-inch and 17-inch separately. Three models are all build-in Lithium-ion battery, support software upgrade online and networking.
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    K Number
    K220362
    Device Name
    LE-12CH
    Manufacturer
    CAF Medical Solutions Inc.
    Date Cleared
    2022-03-25

    (45 days)

    Product Code
    DPS
    Regulation Number
    870.2340
    Why did this record match?
    Applicant Name (Manufacturer) :

    CAF Medical Solutions Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of LE-12CH electrocardiograph is to acquire ECG signals from adult and pediatric patients (beginning at birth through 21 vears of age) through body surface FCG electrocardiograph is only intended to be used in hospitals or healthcare facilities by doctors and trained healtheare professionals. The cardiogram recorded by the electrocardiograph can help users to analyze and diagnose heart disease. However, the interpreted ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only.
    Device Description
    CAF Medical's LE-12CH electrocardiograph device is a twelve-channel electrocardiograph, which features a user-friendly design, a high-resolution 8.4-inch (800*600) TFT LCD touch screen, an alphanumeric keypad and an optimized workflow. The LE-12CH electrocardiograph can acquire 12-channel waveforms simultaneously, and can also print the 12-channel electrocardiograph waveforms simultaneously, using a 216 mm wide thermal printer. An advanced digital filtering technique has been used in the LE-12CH device, including a baseline anti-drift filter, AC noise filter (50/60 Hz), EMG filter and low-pass filter, which can help the user record the ECG more clearly. The LE-12CH electrocardiograph works by sampling the ECG signal from the patient's skin surface using special electrodes. This signal is then amplified and sampled in A/D format by the ECG board. The ECG board transfers the data to the system's MCU via UART. The MCU filters the data, sends it to the LCD, prints the waveforms on paper and stores the data in memory. This log can be stored in flash memory or sent to the PC via Ethernet, WIFI or RS232. During the examination, no substances are given to or removed from the patient. The LE-12CH electrocardiograph supports cardiac stress testing.
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