COMPASS


Device Classification Name

accelerator, linear, medical

510(k) Number K072374
Device Name COMPASS
Applicant
SCANDITRONIX WELLHOFER GMBH
bahnofstrasse 5
schwarzenbruck, 

DE

90592

Applicant Contact martin arold
Correspondent
SCANDITRONIX WELLHOFER GMBH
bahnofstrasse 5
schwarzenbruck, 

DE

90592

Correspodent Contact martin arold
Regulation Number 892.5050
Classification Product Code
IYE  
Date Received 08/23/2007
Decision Date 12/07/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls