510(k) K191387 ยท KNT Tubes, Gastrointestinal (And Accessories)
ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feeding Tube
| Applicant | Envizion Medical , Ltd., Tel Aviv, IL |
| Decision | Substantially Equivalent, Jun 14, 2019 |
| Received | May 24, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K191387
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.