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The predicate devices are the S/5TM FM Monitor (K043276) with E-PSM (K062576), the CARESCAPE V 100 Vital Signs Monitor (K073203) and CARESCAPE Monitor B650 (K 102239). The PROCARE Monitor B40 has the identical arrhythmia algorithm, EK-Pro V12, as the CARESCAPE Monitor 8650 (K 102239).
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17 Nov 2011 GE Healthcare. CARESCAPE Monitor B650. Technical Manual. Software Version 1. Conformity according to the Council Directive 93/42/EEC concerning Medical Devices amended by 2007/47/EC. All specifications subject to change without notice. English. Order code: M1191150 (CD), M1120168 (paper).
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13 Mar 2014 GE Healthcare. CARESCAPE Monitor B450. Technical Manual. Software Version 2. Hardware Version B450- 01. All specifications subject to change without notice. The information in this manual applies to the software and hardware versions listed on the first page of this manual. Due to continuing
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