OEC(R) 9800, OEC(R) 9800 PLUS


Device Classification Name

interventional fluoroscopic x-ray system

510(k) Number K111551
Device Name OEC(R) 9800, OEC(R) 9800 PLUS
Applicant
GE OEC MEDICAL SYSTEMS, INC
384 wright brothers dr.
salt lake city, 
UT 
84116

Applicant Contact gerald buss
Correspondent
GE OEC MEDICAL SYSTEMS, INC
384 wright brothers dr.
salt lake city, 
UT 
84116

Correspodent Contact gerald buss
Regulation Number 892.1650
Classification Product Code
OWB  
Subsequent Product Codes
JAA   OXO  
Date Received 06/03/2011
Decision Date 10/04/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls