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CDSCO UID IMP/MD/2023/001158_d2c256fe447e0d61f711f3f1b6d2b0d2_fd2c38c6fa2d9c5b9819a2c87cdc2381

Multiparameter Monitor with Critical Parameters

Wipro GE Healthcare Private Limited·Device Class Class C·India CDSCO·Brand: Carescape B650
Registration details
UID
IMP/MD/2023/001158_d2c256fe447e0d61f711f3f1b6d2b0d2_fd2c38c6fa2d9c5b9819a2c87cdc2381
Device class
Class C
Brand name
Carescape B650
License holder
Wipro GE Healthcare Private Limited
Approving authority
CDSCO
Product information
The CARESCAPE B650 is intended for multi-parameter patient monitoring of hemodynamic, respiratory and neurophysiological status. The CARESCAPE B650 is a multi-parameter patient monitor intended for use in multiple areas and intra hospital transport within a professional healthcare facility. The CARESCAPE B650 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE B650 also provides alarms, trends, snapshots and events, and calculations, and can be connected to displays, printers and recording devices. The CARESCAPE B650 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for remote viewing and to data management software devices via a network. The CARESCAPE B650 is able to detect and generate alarms for ECG arrhythmias: atrial fibrillation, accelerated ventricular rhythm, asystole, bigeminy, bradycardia, ventricular couplet, irregular, missing beat, multifocal premature ventricular contractions (Carescape B650), pause, R on T, supra ventricular tachycardia, tachycardia, trigeminy, ventricular bradycardia, ventricular fibrillation/ventricular tachycardia, ventricular tachycardia, and VT>2. The CARESCAPE B650 also shows alarms from other ECG sources The CARESCAPE B650 is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility
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About this record

Multiparameter Monitor with Critical Parameters is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/001158_d2c256fe447e0d61f711f3f1b6d2b0d2_fd2c38c6fa2d9c5b9819a2c87cdc2381. This device is marketed under the brand name Carescape B650. The license holder is Wipro GE Healthcare Private Limited, and it is classified as Device Class Class C. The approving authority is CDSCO.

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