Device Classification Name |
Stethoscope, Electronic
|
510(k) Number |
K151319 |
Device Name |
Eko Electronic Stethoscope System |
Applicant |
Eko Devices, Inc. |
2600 10th St, Suite 260 |
Berkeley,
CA
94710
|
|
Applicant Contact |
Connor Landgraf |
Correspondent |
Righter Consulting Group, LLC |
PO BOX 63 |
Tolovana Park,
OR
97145
|
|
Correspondent Contact |
Michael Righter |
Regulation Number | 870.1875
|
Classification Product Code |
|
Date Received | 05/18/2015 |
Decision Date | 08/28/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|