510(k) K212296 ยท FDS Gastroscope And Accessories, Flexible/Rigid
Distal Cap Model DH-32EN, Distal Cap Model DH-17EN2
| Applicant | Fujifilm Corporation, Ashigara Kami-Gun, JP |
| Decision | Substantially Equivalent, Aug 19, 2021 |
| Received | Jul 22, 2021 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K212296
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.