FLIGHT 60 VENTILATOR


Device Classification Name

ventilator, continuous, facility use

510(k) Number K111683
Device Name FLIGHT 60 VENTILATOR
Applicant
FLIGHT MEDICAL INNOVATIONS LTD.
1914 jn pease place
charlotte, 
NC 
28262

Applicant Contact shoshana friedman
Correspondent
FLIGHT MEDICAL INNOVATIONS LTD.
1914 jn pease place
charlotte, 
NC 
28262

Correspodent Contact shoshana friedman
Regulation Number 868.5895
Classification Product Code
CBK  
Subsequent Product Code
NOU  
Date Received 06/15/2011
Decision Date 10/31/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No