The following data is part of a De Novo classification by Proteus Biomedical, Inc. with the FDA for Proteus Ingestion Confinmation Systems.
| DeNovo ID | DEN120011 |
| Device Name: | PROTEUS INGESTION CONFINMATION SYSTEMS |
| Classification | Ingestible Event Marker |
| Applicant | PROTEUS BIOMEDICAL, INC. 2600 Bridge Parkway suite 101 Redwood City, CA 94065 |
| Contact | Jafar Shenasa |
| Product Code | OZW |
| CFR Regulation Number | 880.6305 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | K113070 |
| Review Advisory Board | Gastroenterology/Urology |
| Classification Advisory | General Hospital |
| Type | Post-NSE |
| Date Received | 2012-05-11 |
| Decision Date | 2012-07-10 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |