Device Classification Name |
Stethoscope, Electronic
|
510(k) Number |
K170874 |
Device Name |
Eko Model E5 System (EME5), Eko DUO |
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 |
|
Subsequent Product Code |
|
Date Received | 03/24/2017 |
Decision Date | 05/19/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|