510(k) K191421 ยท OHV Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
Sofacia System
| Applicant | Sofwave Medical, Ltd., Yokneam, IL |
| Decision | Substantially Equivalent, Sep 9, 2019 |
| Received | May 28, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191421
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.