Device Classification Name |
Electrocardiograph
|
510(k) Number |
K031557 |
Device Name |
CARDIOVIT AT-102 |
Applicant |
SCHILLER AG |
ALTGASSE 68 |
BAAR,
CH
CH-6341
|
|
Applicant Contact |
MARKUS BUETLER |
Correspondent |
SCHILLER AG |
ALTGASSE 68 |
BAAR,
CH
CH-6341
|
|
Correspondent Contact |
MARKUS BUETLER |
Regulation Number | 870.2340
|
Classification Product Code |
|
Date Received | 05/19/2003 |
Decision Date | 04/14/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|