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510(k) Data Aggregation
K Number
K211619Device Name
Multi-Parameter Patient Monitor
Manufacturer
Shenzhen Comen Medical Instruments CO., LTD.
Date Cleared
2022-12-29
(582 days)
Product Code
MHX, CBQ, CBS, CCK, CCL, DPS, DQA, DRT, DSB, DSI, DSJ, DSK, DXG, DXN, FLL, GXY, MLD, NHO, NHP, NHQ, OLW
Regulation Number
870.1025Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Comen Medical Instruments CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NC10 and NC12 patient monitors are intended to be used for monitoring, displaying, alarming and storing of multiple physiological parameters These parameters include ECG (3-lead or 12-lead selectable, arrhythmia detection, heart rate (HR)), Respiration rate (RR), temperature (Temp), SpO2, pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), cardiac output (C.O.), carbon dioxide (CO2), anesthetic gas (AG), and Bispectral index (BIS) for a single patient.
All parameters can be monitored on single adult, pediatric, and neonatal patients except:
- · BIS monitoring is intended for adult and pediatric patients only;
- · C.O. monitoring is restricted to adult patients only;
· Arrhythmia analysis is intended to use on adult patients only and is not intended and shall not be used on pediatric and neonatal population.
- · When using COMEM SpO2, the monitor is intended to be used on adult patients only.
- · NIBP measurement continual mode is not applicable to neonates.
The monitors are to be used in general healthes by clinical physicians or appropriate medical staff under the direction of physicians.
The monitors are not intended for helicopter transport, hospital ambulance, or home use.
The monitors do not measure, display, or trend changes in the ST segment.
The monitors do 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
The NC10 and NC12 patient monitors are intended to be used for monitoring, displaying, reviewing, alarming and storing multiple physiological parameters. These parameters include ECG (3-lead, 5-lead or 12-lead selectable, arrhythmia detection, heart rate (HR)), Respiration rate (RR), temperature (Temp), SpO2, pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), cardiac output (C.O.), carbon dioxide (CO2), anesthetic gas (AG), and Bispectral index (BIS) for a single patient.
All parameters can be monitored on single adult, pediatric, and neonatal patients except:
BIS monitoring is intended for adult patients only; C.O. monitoring is restricted to adult patients only; Arrhythmia analysis is intended for use with adult patients only and is not intended and shall not be used on pediatric and neonatal population. When using COMEM SpO2, the monitor is intended to be used on adult patients only. NIBP measurement continual mode is not applicable to neonates. Both models are designed with:
Same system framework and components
Same hardware design principle
Same software platform
Same parameters measurement subsystems (including parameters modules and accessories)
The only difference between NC10 and NC12 is the display size.
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