SIGMA


codes

Device Classification Name

system,x-ray,extraoral source,digital

510(k) Number K001928
Device Name SIGMA
Original Applicant
INSTRUMENTARIUM IMAGING, INC.
300 west edgerton ave.
milwaukee, 
WI 
53207 -6025

Original Contact doug woods
Regulation Number 872.1800
Classification Product Code
MUH  
Date Received 06/26/2000
Decision Date 08/02/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Radiology

Type Traditional
Reviewed by Third Party No

Combination Product

No