VERISUITE 1.6, VERISUITE-PARTICLE 1.6


Device Classification Name

accelerator, linear, medical

510(k) Number K080742
Device Name VERISUITE 1.6, VERISUITE-PARTICLE 1.6
Applicant
MEDCOM GMBH
rundeturmstr. 12
darmstadt, hessen, 

DE

64283

Applicant Contact stefan walter
Correspondent
MEDCOM GMBH
rundeturmstr. 12
darmstadt, hessen, 

DE

64283

Correspodent Contact stefan walter
Regulation Number 892.5050
Classification Product Code
IYE  
Date Received 03/17/2008
Decision Date 05/09/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No