510(k) K211483 ยท OHV Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
SofWave System
| Applicant | Sofwave Medical, Ltd., Yokneam Ilit, IL |
| Decision | Substantially Equivalent, Nov 15, 2021 |
| Received | May 12, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211483
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.