The following data is part of a premarket notification filed by Profound Medical Inc. with the FDA for Tulsa-pro System.
| Device ID | K211858 |
| 510k Number | K211858 |
| Device Name: | TULSA-PRO System |
| Classification | High Intensity Ultrasound System For Prostate Tissue Ablation |
| Applicant | Profound Medical Inc. 2400 Skymark Avenue Unit #6 Mississauga, CA L4W 5K5 |
| Contact | Goldy Singh |
| Correspondent | Goldy Singh Profound Medical Inc. 2400 Skymark Avenue Unit #6 Mississauga, CA L4W 5K5 |
| Product Code | PLP |
| CFR Regulation Number | 876.4340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-16 |
| Decision Date | 2022-09-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07540281001400 | K211858 | 000 |
| 07540281001370 | K211858 | 000 |