K251088
- 510(k) number
- K251088
- Device name
- Otsuka Digital Feedback Device
- Applicant
- Otsuka America Pharmaceutical, Inc. CA · US
- Product code
- OZW — Ingestible Event Marker
- Decision date
- 2025-06-30
- Date received
- 2025-04-09
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
510(k) Summary (official FDA PDF): K251088.pdf
Official FDA record: K251088
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.