510(k) K191366 ยท OCX Endoscopic Irrigation/Suction System
Vacutore Air/Water Bottle Tubing
| Applicant | Smartdata Suzhou Co., Ltd., Suzhou, CN |
| Decision | Substantially Equivalent, Sep 6, 2019 |
| Received | May 22, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191366
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.