DRF 4343


Device Classification Name

system, x-ray, fluoroscopic, image-intensified

510(k) Number K080859
Device Name DRF 4343
Applicant
VILLA SISTEMI MEDICALI S.P.A.
via delle azalee 3
buccinasco, 

IT

20090

Applicant Contact paolo c santin
Correspondent
VILLA SISTEMI MEDICALI S.P.A.
via delle azalee 3
buccinasco, 

IT

20090

Correspodent Contact paolo c santin
Regulation Number 892.1650
Classification Product Code
JAA  
Subsequent Product Code
MQB  
Date Received 03/27/2008
Decision Date 06/04/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No