RoboELF - JHU Internal Use Only Material

Material for FDA Submission

Document Link Last Edit Responsible Person Ready for Submission
 Electrical Schematic 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

Design Documents

Meeting Documents

Review Meeting Sign-in Sheets:

research/roboelf_jhu_only.txt · Last modified: 2019/08/07 16:01 by 127.0.0.1




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