Classification - CareFusion AVEA Operating Instructions Manual

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Classification

Type of Equipment:
Declaration of Conformity Notice
This medical equipment complies with the Medical Device Directive, 93/42/EEC,
and the following Technical Standards, to which Conformity is declared:
BS EN 60601-2-12:2006
EN 60601-1
EN 60601-1-2
ISO 13485
UL 60601-1
CAN / CSA C22.2 No. 601.1.12-94 (R99)
EU Notified Body:
BSI (Reg. No. 0086)
Trade names:
AVEA ventilator systems
Manufactured by:
CareFusion
22745 Savi Ranch Parkway
Yorba Linda, California 92887-4668
USA
If you have a question regarding the Declaration of Conformity for this product, please contact CareFusion at one of the
numbers given in Appendix A.
Medical Equipment, Class 1 type B
Adult/Pediatric/Infant Lung Ventilator
Operator's manual
L2786 Rev. M