OEC FLUOROTRAK 9800 PLUS


Device Classification Name

interventional fluoroscopic x-ray system

510(k) Number K022069
Device Name OEC FLUOROTRAK 9800 PLUS
Original Applicant
GE OEC MEDICAL SYSTEMS
384 wright brothers dr.
salt lake city, 
UT 
84116

Original Contact bill gislason
Regulation Number 892.1650
Classification Product Code
OWB  
Subsequent Product Codes
JAA   OXO  
Date Received 06/25/2002
Decision Date 09/17/2002
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