Device Classification Name |
Electrocardiograph Software For Over-The-Counter Use
|
510(k) Number |
K201168 |
Device Name |
ECG Monitor App |
Applicant |
Samsung Electronics Co., Ltd |
129, Samsung-ro, Yeongtong-gu, |
Suwon-si,
KR
16677
|
|
Applicant Contact |
Taejong Jay Yang |
Correspondent |
Samsung Electronics Co., Ltd |
665 Clyde Avenue |
Mountain View,
CA
94043
|
|
Correspondent Contact |
Matthew Wiggins |
Regulation Number | 870.2345
|
Classification Product Code |
|
Date Received | 05/01/2020 |
Decision Date | 08/04/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|