Ivy Biomedical Systems 3150-B Manual De Instrucciones página 5

Declaration of Conformity
Manufacturer:
Authorized Representative:
Type of Equipment:
Models:
We, Ivy Biomedical Systems, Inc., hereby declare that the devices mentioned above
comply with the Swedish National Board of Health and Welfare Regulation and
guidelines on medical devices LVFS 2003:11 (M) 28 October 1994 – transposing
European Medical Devices Directive 93/42/EEC.
Date of Validity:
Classification:
Conformity Assessment
Procedure:
Notified Body:
Name of Authorized Signatory:
Position held in Company:
Signature
IIb
Intertek SEMKO AB
Director of Regulatory
Ivy Biomedical Systems, Inc.
11 Business Park Drive
Branford, CT 06405
Cavendish Scott Ltd.
Starlings Bridge, Nightingale Road
Hitchin, Herts, SG5 1FW, England
Physiological Monitors
3150 (B Option)
March 30, 2010
According to rule No.
Annex II
Notified Body No.
Dick Listro
10
0413