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
|
|
|