ORG@NIZER, MODEL VERSION 3.0


Device Classification Name

system, image processing, radiological

510(k) Number K030363
Device Name ORG@NIZER, MODEL VERSION 3.0
Applicant
EBIT SANITA, S.P.A.
7992 castleway dr.
indianpolis, 
IN 
46250

Applicant Contact colleen densmore
Correspondent
EBIT SANITA, S.P.A.
7992 castleway dr.
indianpolis, 
IN 
46250

Correspodent Contact colleen densmore
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 02/04/2003
Decision Date 03/27/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No