Declaration Of Conformity - Progetti RESCUE SAM ELRS-002 Manuel D'utilisation

C
TO
MANUFACTURER :
PRODUCT/MODEL :
CLASSIFICATION :
CONFORMITY ASSESSMENT ROUTE:
W
E HEREWITH DECLARE THAT THE ABOVE MENTIONED PRODUCT(S) MEET THE TRANSPOSITION INTO NATIONAL
LAW, THE PROVISIONS OF
ALL SUPPORTING DOCUMENTATION IS RETAINED AT THE PREMISES OF THE MANUFACTURER.
STANDARDS APPLIED:
NOTIFIED BODY :
IDENTIFICATION NUMBER :
Conformity Certificate N°:
Expire date:
EC-Type Certificate N°:
Expire date:
PLACE, DATE OF ISSUE :
SIGNATURE :
D
ECLARATION OF
D
OUNCIL IRECTIVE
CONCERNING
PROGETTI s.r.l.
Via B. Buozzi, 28
10024 Moncalieri – TO, ITALY
Defibrillator/ RESCUE SAM
GMDNS Code: 11132, Defibrillators
Class II B, Rule 10 According To Annex III and VI of the MDD
Council Directive 93/43/EEC (MDD), Annex II
C D 93/42/EEC
OUNCIL IRECTIVE
ISO 13485:2004, CEI EN 60601-1-2:2003, CEI EN 60601-1:2007,
CEI EN 60601-2-4:2004
ISTITUTO DI RICERCHE E COLLAUDI M. MASINI S.r.l.
Via Moscova, 11
20017 Rho - MI, ITALY
0068/QPR – DM/020-2010 Rev. 3 of 13/12/2010
March 15, 2013
0068/ETI-DM/017-2010 Rev. 1 of 25/10/2010
March 15, 2015
MONCALIERI (TO) , 2010-10-28
NAME
LEGAL REPRESENTATIVE
RESCUE SAM User Manual vers.1.0 March 2011
C
ONFORMITY
93/42/EEC 14 J
OF
M D
EDICAL EVICES
14 J 1993
OF UNE CONCERNING MEDICAL DEVICES.
0068
Dr. CESARE MANGONE
1993
UNE
29