IVENT 2001 MRI CONDITIONAL


Device Classification Name

ventilator, continuous, facility use

510(k) Number K073694
Device Name IVENT 2001 MRI CONDITIONAL
Applicant
VERSAMED MEDICAL SYSTEMS, INC.
3460 pointe creek ct
suite 102
bonita springs, 
FL 
34134 -2015

Applicant Contact paul dryden
Correspondent
VERSAMED MEDICAL SYSTEMS, INC.
3460 pointe creek ct
suite 102
bonita springs, 
FL 
34134 -2015

Correspodent Contact paul dryden
Regulation Number 868.5895
Classification Product Code
CBK  
Date Received 12/31/2007
Decision Date 05/30/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No