510(k) K191503 ยท OWB Interventional Fluoroscopic X-Ray System
MobileRay Pulse SE Digital Imaging System
| Applicant | Portavision Medical, LLC, Jefferson LA, US |
| Decision | Substantially Equivalent, Sep 4, 2019 |
| Received | Jun 6, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191503
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.