Device Classification Name |
Ingestible Event Marker
|
510(k) Number |
K150494 |
Device Name |
Proteus Digital Health Feedback Device |
Applicant |
PROTEUS DIGITAL HEALTH, INC. |
2600 BRIDGE PARKWAY, SUITE 101 |
REDWOOD CITY,
CA
94065
|
|
Applicant Contact |
Jessie Duong |
Correspondent |
PROTEUS DIGITAL HEALTH, INC. |
2600 BRIDGE PARKWAY, SUITE 101 |
REDWOOD CITY,
CA
94065
|
|
Correspondent Contact |
Jafar Shenasa |
Regulation Number | 880.6305
|
Classification Product Code |
|
Date Received | 02/25/2015 |
Decision Date | 06/27/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|