RoboELF - JHU Internal Use Only Material

Material for FDA Submission

Document Link	Last Edit	Responsible Person	Ready for Submission
	4-8-13	Kevin	Yes
Robo-ELF Clinical Poster	4-8-13	Kevin	Yes
Laryngoscope Paper	4-8-13	Kevin	Yes
User Manual, pdf	3-18-13	Kevin	Yes
Software Overview: ppt, pdf	12-4-12	Jon	Yes
Software Documentation, pdf	3-14-13	Jon	Yes
FMEA and Test Plan, FMEA, Test Plan	3-25-13	Jon	Yes
FDA Response to previous submission	10-25-11	Kevin	Yes
Response to Concerns, pdf	3-18-13	Kevin/Dr. Richmon	Yes
Maintenance Manual, pdf	2-27-13	Kevin	Yes
Maintenance Check List, pdf	2-27-13	Kevin	Yes
Technical Description, pdf	3-18-13	Kevin	Yes
Clinical Updates	-	Dr. Richmon	Yes
IRB Protocol , pdf	3-25-13	Dr. Richmon	Yes