510(k) K190255 ยท JAD System, Therapeutic, X-Ray
Sensus Healthcare TVM Balloon Applicator
| Applicant | Sensus Healthcare, Inc., Boca Raton FL, US |
| Decision | Substantially Equivalent, Feb 21, 2019 |
| Received | Feb 7, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190255
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.