Device Classification Name |
electrocardiograph
|
510(k) Number |
K152043 |
Device Name |
Diagnostic Station DS20 |
Applicant |
SCHILLER AG |
ALTGASSE 68 |
baar,
CH
ch-6341
|
|
Applicant Contact |
zhenrong yu |
Correspondent |
ZOE MEDICAL, INC. |
460 BOSTON STREET |
topsfield,
MA
01983
|
|
Correspondent Contact |
jim chickering |
Regulation Number | 870.2340
|
Classification Product Code |
|
Date Received | 07/23/2015 |
Decision Date | 05/06/2016 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
summary |
summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|