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DEVICE DETAILS

NAME OF DEVICEPULSE OXIMETER
ESTABLISHMENT NAMEPELANGI PROGRESIF SDN. BHD.
ROLE OF ESTABLISHMENTAUTHORIZED REPRESENTATIVE
REGISTRATION NOGC6325423-142656
BRAND NAMEBIOLIGHT
MEDICAL DEVICE CATEGORYMD 1302 - Monitoring devices of vital physiological parameters
DEVICE GROUPING TYPEFAMILY
DEVICE DESCRIPTIONPatient Monitor M800 monitor significant vital sign parameters of patients, including SpO2 and pulse rate.
DEVICE INTENDED PURPOSEThe M800 handheld monitor is intended for continuous or spot check monitoring of functional arterial oxygen saturation (SpO2) and pulse rate of adult, pediatric and neonatal patients in hospital, hospital type facilities, transport and mobile environments as well as in the home care environment.
VALIDITY DATE OF REGISTRATION25/07/2023 - 24/07/2028

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
1Patient monitor M800
2BLT digital SpO2 adult reusable sensor                                        15-100-0013
3AA alkaline battery AA Battery
4LB-03 Lithium battery 12-033-0001
5M800 Battery charger stand & AC-DC adapter23-033-0001
6ECG Cable15-031-0004
7Disposable Adhesive Electrodes15-100-0008
8User's Manual                    Manual
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