510(k) K201743 ยท OWB Interventional Fluoroscopic X-Ray System
ClarifEye R1.0, ClarifEye Needle
| Applicant | Philips Medical Systems Nederlands B.V., Best, NL |
| Decision | Substantially Equivalent, Feb 23, 2021 |
| Received | Jun 25, 2020 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K201743
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.