4D MV-ASSESSMENT 2.0


Device Classification Name

computer, diagnostic, programmable

510(k) Number K103782
Device Name 4D MV-ASSESSMENT 2.0
Applicant
TOMTEC IMAGING SYSTEMS, GMBH
edisonstrasse 6
unterschleissheim, 

DE

d-85716

Applicant Contact inge scheidt
Correspondent
TOMTEC IMAGING SYSTEMS, GMBH
edisonstrasse 6
unterschleissheim, 

DE

d-85716

Correspodent Contact inge scheidt
Regulation Number 870.1425
Classification Product Code
DQK  
Date Received 12/27/2010
Decision Date 01/27/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No