INNOVA 2000 AND INNOVA 2000S (MOBILE VERSION)


Device Classification Name

interventional fluoroscopic x-ray system

510(k) Number K024200
Device Name INNOVA 2000 AND INNOVA 2000S (MOBILE VERSION)
Original Applicant
GE MEDICAL SYSTEMS, INC.
p.o. box 414
milwaukee, 
WI 
53201

Original Contact larry a kroger
Regulation Number 892.1650
Classification Product Code
OWB  
Subsequent Product Codes
JAA   OXO  
Date Received 12/20/2002
Decision Date 01/16/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls