STRATO X


information about

Device Classification Name

unit, x-ray, extraoral with timer

510(k) Number K002432
Device Name STRATO X
Original Applicant
VILLA SISTEMI MEDICALI S.P.A.
11550 west king st.
franklin park, 
IL 
60131

Original Contact jeff moeller
Regulation Number 872.1800
Classification Product Code
EHD  
Date Received 08/08/2000
Decision Date 09/01/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Radiology

Type Traditional
Reviewed by Third Party No

Combination Product

No