INTEGRATED INNOVA – S5I SYSTEM OPTION


Device Classification Name

system, x-ray, angiographic

510(k) Number K111209
Device Name INTEGRATED INNOVA – S5I SYSTEM OPTION
Applicant
GE HEALTHCARE
283, rue de la miniere
buc, 

FR

78530

Applicant Contact faycal kherra
Correspondent
GE HEALTHCARE
283, rue de la miniere
buc, 

FR

78530

Correspodent Contact faycal kherra
Regulation Number 892.1600
Classification Product Code
IZI  
Date Received 04/29/2011
Decision Date 07/26/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No