Device Classification Name |
electrocardiograph software for over-the-counter use
|
510(k) Number |
K201525 |
Device Name |
ECG App |
Applicant |
Apple Inc. |
One Apple Park Way |
cupertino,
CA
94015
|
|
Applicant Contact |
luke olson |
Correspondent |
Apple Inc. |
One Apple Park Way |
cupertino,
CA
94015
|
|
Correspondent Contact |
luke olson |
Regulation Number | 870.2345
|
Classification Product Code |
|
Date Received | 06/08/2020 |
Decision Date | 10/08/2020 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
summary |
summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|