Pair of Adult Radiopaque Lead Out multifunction pads for Zoll Medical, M&D devices
Comply with European Directive and International Standards
(IEC/EN 60601-1, IEC/EN 60601-2- 4, ANSI/AAMI DF-80, EN ISO 10993-1)
MADE IN ITALY
The Pads are manufactured in accordance with the applicable European regulations (CE) on medical devices and meet the requirements of harmonized standards that apply to them. Regulatory requirements set by the Countries under MDSAP scheme are also applied: Australian ATGMDR 2002, Brazilian ANVISA RDC, Canadian CMDR, Japanese MHLW Ordinance no.169, U.S. FDA CFR Title 21 Part 820.