Declaration of conformity
Manufacturer: COSMED S.r.l.
Address: Via dei Piani di Monte Savello 37
00041 Albano Laziale (RM)
ITALY
phone: +39-06-9315492
fax: +39-06-9314580
manufacturer of the following equipment:
K5
declares under his sole responsibility that:
• the above listed equipment comply with the essential requirements of the Annex I of the Medical Device Directive 93/42/EEC;
• are classified in Class IIa;
• their design, manufacturing and final checks are performed according the Cosmed’s Quality System, conform to ISO 9001:2008 and
ISO13485:2003 Norms, certified by KIWA CERMET (certificates nr. 387-A and 387-M);
• are CE marked according to the Medical Device Directive 93/42/EEC and certified by KIWA CERMET (certificate nr. MED 9811).
The equipment conform with the following specifications:
Safety: IEC 60601-1
EMC: IEC 60601-1-2
64 - Appendix - Declaration of conformity
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