510(k) K231537 ยท OHV Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
SofWave System
| Applicant | Sofwave Medical, Ltd., Yokneam Iiit, IL |
| Decision | Substantially Equivalent, Aug 28, 2023 |
| Received | May 30, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K231537
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.