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Anesthesiology and Respiratory Therapy Devices Panel

May 28,2009

BRIEFING INFORMATION

FDA

Disclaimer
The statements contained in this document(s) are those of the product's sponsor, not FDA
and FDA does not necessarily agree with the sponsor's statements. FDA has not made a
3nal determination about the safety or effectiveness of the product described in this
document.

FDA Executive Summary (pdf)
Voting Options (pdf)
FDA Questions (pdf)

Sponsor

Disclaimer
Portions of this document have been determined to be exempt from disclosure under the
Freedom of Information Act (the FOIA) (5 Y.s.c. $552) These redactedportions will
appear as white spaces on thescreen or on the printedpage.

Sponsors Executive Summary (pdf)
Clinical User Guide / Operator's Manual (pdf)
Clinical User Guide / Operator's Manual (pdf)

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