BRIVO XR385


Device Classification Name

system, x-ray, stationary

510(k) Number K103448
Device Name BRIVO XR385
Applicant
GE MEDICAL SYSTEMS, LLC
3000 n grandview blvd.
waukesha, 
WI 
53188

Applicant Contact john l schmidt
Correspondent
GE MEDICAL SYSTEMS, LLC
3000 n grandview blvd.
waukesha, 
WI 
53188

Correspodent Contact john l schmidt
Regulation Number 892.1680
Classification Product Code
KPR  
Date Received 11/24/2010
Decision Date 08/12/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No