510(k) K221309 ยท JOY Device, Automated Cell-Locating
AI100 with Shonit
| Applicant | Sigtuple Technologies Pvt. , Ltd., Bangalore, IN |
| Decision | Substantially Equivalent, Sep 19, 2023 |
| Received | May 5, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221309
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.