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DEVICE DETAILS

NAME OF DEVICEPULSE OXIMETER (H100N, H100B)
ESTABLISHMENT NAMEKORMED RESOURCES PLT.
REGISTRATION NOGC374031090618
BRAND NAMEEDAN
DEVICE GROUPING TYPEFAMILY
DEVICE DESCRIPTIONH100B AND H100N (BOTH IN FIGURE 1) ARE MODELS OF H100 SERIES PULSE OXIMETER. IT DISPLAYS SPO2 VALUE, PULSE RATE VALUE, PLETHYSMOGRAM, BAR GRAPH, TEMPERATURE, ETC. H100B IS INSTALLED WITH EDAN SPO2 MODULE INSIDE. H100N IS INSTALLED WITH NELLCOR SPO2 MODULE AND THE MANUFACTURER’S TEMP MODULE INSIDE. IT INTEGRATES PARAMETER MODULE, DISPLAY AND DATA OUTPUT FUNCTIONS.
DEVICE INTENDED PURPOSETHE H100B PULSE OXIMETER IS INTENDED FOR CONTINUOUS MONITORING OR SPOT-CHECKING OF FUNCTIONAL ARTERIAL OXYGEN SATURATION (SPO2) AND PULSE RATE OF SINGLE ADULT, PEDIATRIC OR NEONATE PATIENT IN HOSPITALS, INTRA-HOSPITAL TRANSPORT AND HOSPITAL TYPE FACILITIES.
VALIDITY DATE OF REGISTRATION26/09/2018 - 25/09/2023

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
1Pulse OximeterH100B
2Pulse OximeterH100N
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