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Panorama™ Operating Instructions 0070-10-0690-01
Declaration of Conformity
Manufacturer: Datascope Corp.
800 MacArthur Blvd
Mahwah, NJ 07430
European Representative: Datascope BV
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
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
Notified Body:
RWTÜV Systems GmbH
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