VAR MONITOR


Device Classification Name

ventilator, emergency, powered (resuscitator)

510(k) Number K073261
Device Name VAR MONITOR
Applicant
VORTRAN MEDICAL TECHNOLOGY 1, INC.
21 golden land court
sacramento, 
CA 
95834

Applicant Contact james lee
Correspondent
VORTRAN MEDICAL TECHNOLOGY 1, INC.
21 golden land court
sacramento, 
CA 
95834

Correspodent Contact james lee
Regulation Number 868.5925
Classification Product Code
BTL  
Date Received 11/20/2007
Decision Date 05/23/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No