Mindray DS USA Inc. WT0707-00000 ユーザーズマニュアル
Panorama™ Operating Instructions
0070-10-0690-01
Declaration of Conformity
Manufacturer:
Datascope Corp.
800 MacArthur Blvd
Mahwah, NJ 07430
800 MacArthur Blvd
Mahwah, NJ 07430
European Representative:
Datascope BV
Drs. W van Royenstraat 8,
3871 AN Hoevalaken,
The Netherlands
Drs. W van Royenstraat 8,
3871 AN Hoevalaken,
The Netherlands
Product category:
Central Monitoring System
Model
Panorama Patient Monitoring Network Software
Classification (per Annex II):
Class IIb (marked CE 0044)
Model
Panorama Central Station and
Panorama Telemetry Server
Panorama Telemetry Server
Classification (per Annex II):
Class I (marked CE)
Conformity Route:
Annex II, Clause 3
We herewith declare that the above mentioned product meets the provisions of the
Council Directive 93/42/EEC for the Medical Devices. All Supporting documentation is
retained under the premises of Datascope Corp., Mahwah, NJ 07430
Council Directive 93/42/EEC for the Medical Devices. All Supporting documentation is
retained under the premises of Datascope Corp., Mahwah, NJ 07430
Notified Body:
RWTÜV Systems GmbH
Silz: Essen
Langemarckstrabe 20
D-45141 Essen, Germany
ID#0044
Silz: Essen
Langemarckstrabe 20
D-45141 Essen, Germany
ID#0044
EC Certificate:
No.: 04 207-770/96
Start of CE-Marking:
September 30, 2004
Signature:
_________________________
Susan E. Mandy
Director of Clinical and Regulatory Affairs
Susan E. Mandy
Director of Clinical and Regulatory Affairs