FDA 510(k) Applications for Medical Device Product Code "OZW"
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K183052 | etectRx, Inc. | ID-Cap System | 12/06/2019 |
| K251088 | Otsuka America Pharmaceutical, Inc. | Otsuka Digital Feedback Device | 06/30/2025 |
| K223463 | Otsuka America Pharmaceutical, Inc. | Otsuka Digital Feedback Device-RW | 08/11/2023 |
| DEN120011 | PROTEUS BIOMEDICAL, INC. | PROTEUS INGESTION CONFINMATION SYSTEMS | 07/10/2012 |
| K150494 | PROTEUS DIGITAL HEALTH, INC. | Proteus Digital Health Feedback Device | 06/27/2015 |
| K131524 | PROTEUS DIGITAL HEALTH, INC. | PROTEUS PATCH INCLUDING INGESTIBLE SENSOR | 06/23/2013 |
| K131009 | PROTEUS DIGITAL HEALTH, INC. | PROTEUS PATCH, INGESTIBLE SENSOR (ACCESSORY) | 05/07/2013 |
| K133263 | PROTEUS DIGITAL HEALTH, INC. | PROTEUS PATCH, PROTEUS INGESTIBLE SENSOR (ACCESSORY) | 02/07/2014 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
