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 |