K231209
- 510(k) number
- K231209
- Device name
- Rejoyn
- Applicant
- Otsuka America Pharmaceutical, Inc. MD · US
- Product code
- SAP — Computerized Behavioral Therapy Device For Depressiv
- Decision date
- 2024-03-30
- Date received
- 2023-04-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 3.2 MB · U.S. public domain
Also available from FDA: K231209.pdf
Official FDA record: K231209
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.