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
|
|
Correspondent Contact |
ALBRECHT MALKMUS |
Regulation Number | 870.1425
|
Classification Product Code |
|
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
|
|
|