FDA Product Code
FDA Product Code OZW — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.6305
510(k) Clearances — 8 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K251088 | Otsuka Digital Feedback Device | Otsuka America Pharmaceutical, Inc. | 2025-06-30 | Traditional | PDF ↗ |
| K223463 | Otsuka Digital Feedback Device-RW | Otsuka America Pharmaceutical, Inc. | 2023-08-11 | Traditional | PDF ↗ |
| K183052 | ID-Cap System | Etectrx, Inc. | 2019-12-06 | Traditional | PDF ↗ |
| K150494 | Proteus Digital Health Feedback Device | Proteus Digital Health, Inc. | 2015-06-27 | Traditional | PDF ↗ |
| K133263 | PROTEUS PATCH, PROTEUS INGESTIBLE SENSOR (ACCESSORY) | Proteus Digital Health, Inc. | 2014-02-07 | Special | PDF ↗ |
| K131524 | PROTEUS PATCH INCLUDING INGESTIBLE SENSOR | Proteus Digital Health, Inc. | 2013-06-23 | Special | PDF ↗ |
| K131009 | PROTEUS PATCH, INGESTIBLE SENSOR (ACCESSORY) | Proteus Digital Health, Inc. | 2013-05-07 | Special | PDF ↗ |
| DEN120011 | PROTEUS INGESTION CONFINMATION SYSTEMS | Proteus Biomedical, Inc. | 2012-07-10 | Post-NSE | — |
Product code OZW · Class II · General Hospital. Data: openFDA.