510(k) K251088
- Device
- Otsuka Digital Feedback Device
- Applicant
- Otsuka America Pharmaceutical, Inc.
- 510(k) number
- K251088
- Product code
- OZW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-06-30
- Date received
- 2025-04-09
- Regulation
- 880.6305
- Classification name
- Ingestible Event Marker
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Nancy Teague
- Address
- 3956 Pt. Eden Way Hayward CA US 94545 94545
FDA Registration Numbers#
- 3010742884
Source Documents#
Other 510(k) Records For Product Code OZW#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K223463 | Otsuka Digital Feedback Device-RW | Otsuka America Pharmaceutical, Inc. | 2023-08-11 |
| K183052 | ID-Cap System | Etectrx, Inc. | 2019-12-06 |
| K150494 | Proteus Digital Health Feedback Device | Proteus Digital Health, Inc. | 2015-06-27 |
| K133263 | PROTEUS PATCH, PROTEUS INGESTIBLE SENSOR (ACCESSORY) | Proteus Digital Health, Inc. | 2014-02-07 |
| K131524 | PROTEUS PATCH INCLUDING INGESTIBLE SENSOR | Proteus Digital Health, Inc. | 2013-06-23 |
| K131009 | PROTEUS PATCH, INGESTIBLE SENSOR (ACCESSORY) | Proteus Digital Health, Inc. | 2013-05-07 |
| DEN120011 | PROTEUS INGESTION CONFINMATION SYSTEMS | Proteus Biomedical, Inc. | 2012-07-10 |