Device Classification Name |
Stethoscope, Electronic
|
510(k) Number |
K200776 |
Device Name |
Eko CORE |
Applicant |
Eko Devices, Inc. |
1212 Broadway, Suite 100 |
Oakland,
CA
94612
|
|
Applicant Contact |
Arezou Azar |
Correspondent |
Eko Devices, Inc. |
1212 Broadway, Suite 100 |
Oakland,
CA
94612
|
|
Correspondent Contact |
Arezou Azar |
Regulation Number | 870.1875
|
Classification Product Code |
|
Date Received | 03/25/2020 |
Decision Date | 04/06/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|