510(k) K202286 ยท PLP High Intensity Ultrasound System For Prostate Tissue Ablation
Tulsa-Pro System
| Applicant | Profound Medical, Inc., Mississauga, CA |
| Decision | Substantially Equivalent, Sep 16, 2020 |
| Received | Aug 12, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K202286
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.