Device Classification Name |
ingestible event marker
|
510(k) Number |
K133263 |
Device Name |
PROTEUS PATCH, PROTEUS INGESTIBLE SENSOR (ACCESSORY) |
Applicant |
PROTEUS DIGITAL HEALTH, INC. |
2600 BRIDGE PARKWAY, SUITE 101 |
redwood city,
CA
94065
|
|
Applicant Contact |
jafar shenasa |
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 |
|
Subsequent Product Code |
|
Date Received | 10/23/2013 |
Decision Date | 02/07/2014 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
Gastroenterology/Urology
|
summary |
summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|