You also want an ePaper? Increase the reach of your titles
YUMPU automatically turns print PDFs into web optimized ePapers that Google loves.
10 Infant Flow ® SiPAP<br />
Declaration of Conformity Notice<br />
This medical equipment complies with the Medical Device Directive, 93/42/EEC, and<br />
the following Technical Standards, to which Conformity is declared:<br />
Council Directive(s): MDD 93/42/EEC Annex II (excluding section 4)<br />
Safety: EN 60601-1, EN 794-1<br />
EMC: EN 60601-1-2:2001<br />
Conformity Assessment: MDD Annex II<br />
Quality System: ISO 13485<br />
EU Notified Body: BSI (Reg. No. 0086)<br />
Device Classification: IIb<br />
EU Notified Body:<br />
BSI (Reg. No. 0086)<br />
Trade names:<br />
Infant Flow SiPAP<br />
Manufactured by:<br />
SensorMedics Corporation<br />
22705 Savi Ranch Parkway<br />
Yorba Linda, CA 92887, USA<br />
If you have a question regarding the Declaration of Conformity for this product,<br />
please contact VIASYS Healthcare, Critical Care Division.<br />
675-120 Revision C November 2004
Change language