CASE CARDIAC TESTING SYSTEM, CS CARDIAC TESTING SYSTEM


Device Classification Name

computer, diagnostic, programmable

510(k) Number K103678
Device Name CASE CARDIAC TESTING SYSTEM, CS CARDIAC TESTING SYSTEM
Applicant
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES GMBH
munzinger strasse 5
freiburg,baden wurttemberg, 

DE

79111

Applicant Contact albrecht malkmus
Correspondent
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES GMBH
munzinger strasse 5
freiburg,baden wurttemberg, 

DE

79111

Correspodent Contact albrecht malkmus
Regulation Number 870.1425
Classification Product Code
DQK  
Date Received 12/16/2010
Decision Date 02/16/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No