510(k) K230692 ยท PLP High Intensity Ultrasound System For Prostate Tissue Ablation
TULSA-PRO System
| Applicant | Profound Medical, Inc., Mississauga, CA |
| Decision | Substantially Equivalent, Sep 20, 2023 |
| Received | Mar 13, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230692
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.