Annex B Declaration Of Conformity - hatch X-RAY Operating Manual

HATCH X-RAY Operating Manual
ANNEX
B
DECLARATION OF CONFORMITY
B1: Name and description of product
Medical Device Name: High Frequency Dental X-Ray System
Medical Device Model: Hatch X-Ray
Device variants:
303-00238X-0 - Hatch X-Ray X-ray with focal spot size 0.4 in wall mount
configuration with Extension arm, where X= 1,2,3
B2: Following standards under which conformity is declared
ANSI/AAMI ES 60601-1: A1:2012 C1: 2009/(R) 2012 and A2:2010/(R) 2012
IEC 60601 - 1: ED 3.1 (2012)
CAN/CSA-C22 .2 No. 60601-1:14
IEC60601-1-2:2014
IEC 60601-1-3: 2008 + A1:2013
EN/IEC 60601-2-65 2012
IEC60601-2-28: 2010
CMDR SOR/98-282
B3: Marking
The products described herein are conform to the following regulatory markings
a. UL safety marking.
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