510(k) K240296 ยท PLP High Intensity Ultrasound System For Prostate Tissue Ablation
Tulsa Pro System (Pad-105)
| Applicant | Profound Medical, Inc., Mississauga, CA |
| Decision | Substantially Equivalent, May 9, 2024 |
| Received | Feb 1, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K240296
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.