The following data is part of a premarket notification filed by Profound Medical Inc with the FDA for Tulsa-pro System.
| Device ID | K202286 |
| 510k Number | K202286 |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-12 |
| Decision Date | 2020-09-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07540281000922 | K202286 | 000 |
| 07540281001233 | K202286 | 000 |
| 07540281000908 | K202286 | 000 |
| 07540281001615 | K202286 | 000 |
| 07540281001660 | K202286 | 000 |
| 07540281001646 | K202286 | 000 |
| 07540281001608 | K202286 | 000 |
| 07540281001592 | K202286 | 000 |
| 07540281001585 | K202286 | 000 |
| 07540281001578 | K202286 | 000 |
| 07540281001240 | K202286 | 000 |
| 07540281001288 | K202286 | 000 |
| 07540281001301 | K202286 | 000 |
| 07540281000915 | K202286 | 000 |
| 07540281000892 | K202286 | 000 |
| 07540281000885 | K202286 | 000 |
| 07540281000878 | K202286 | 000 |
| 07540281000861 | K202286 | 000 |
| 07540281000144 | K202286 | 000 |
| 07540281000137 | K202286 | 000 |
| 07540281000120 | K202286 | 000 |
| 07540281001295 | K202286 | 000 |
| 07540281001561 | K202286 | 000 |