510(k) K231209 ยท SAP Computerized Behavioral Therapy Device For Depressive Disorders.
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| Applicant | Otsuka America Pharmaceutical, Inc., Rockville MD, US |
| Decision | Substantially Equivalent, Mar 30, 2024 |
| Received | Apr 27, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K231209
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.