510(k) K191200 ยท PLP High Intensity Ultrasound System For Prostate Tissue Ablation
TULSA-PRO System
| Applicant | Profound Medical, Inc., Mississauga, CA |
| Decision | Substantially Equivalent, Aug 15, 2019 |
| Received | May 6, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191200
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.