OEC 9900 ELITE


Device Classification Name

interventional fluoroscopic x-ray system

510(k) Number K073543
Device Name OEC 9900 ELITE
Applicant
GE OEC MEDICAL SYSTEMS
384 wright brothers dr.
salt lake city, 
UT 
84116

Applicant Contact maria c frame
Correspondent
GE OEC MEDICAL SYSTEMS
384 wright brothers dr.
salt lake city, 
UT 
84116

Correspodent Contact maria c frame
Regulation Number 892.1650
Classification Product Code
OWB  
Subsequent Product Codes
JAA   OXO  
Date Received 12/17/2007
Decision Date 05/02/2008
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