Device Classification Name |
electrocardiograph
|
510(k) Number |
K183425 |
Device Name |
CARDIOVIT AT-102 G2 |
Applicant |
Schiller AG |
Altgasse 68 |
baar zug,
CH
6341
|
|
Applicant Contact |
sabina standiford |
Correspondent |
Arazy Group Consultants Inc. |
68 Southwood Terrace |
southbury,
CT
06488
|
|
Correspondent Contact |
ray kelly |
Regulation Number | 870.2340
|
Classification Product Code |
|
Date Received | 12/11/2018 |
Decision Date | 03/02/2020 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
statement |
statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|