| 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
|
|---|