The following data is part of a premarket notification filed by Profound Medical Inc. with the FDA for Tulsa-pro System.
| Device ID | K191200 |
| 510k Number | K191200 |
| 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 L4w5k5 |
| Contact | Goldy Singh |
| Correspondent | Goldy Singh PROFOUND MEDICAL INC. 2400 Skymark Avenue, Unit #6 Mississauga, CA L4w5k5 |
| Product Code | PLP |
| CFR Regulation Number | 876.4340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-06 |
| Decision Date | 2019-08-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07540281000182 | K191200 | 000 |
| 07540281000212 | K191200 | 000 |
| 07540281001196 | K191200 | 000 |
| 07540281000847 | K191200 | 000 |
| 07540281000830 | K191200 | 000 |
| 07540281000823 | K191200 | 000 |
| 07540281000816 | K191200 | 000 |
| 07540281001691 | K191200 | 000 |
| 07540281001684 | K191200 | 000 |
| 07540281001677 | K191200 | 000 |
| 07540281001653 | K191200 | 000 |
| 07540281001639 | K191200 | 000 |
| 07540281001554 | K191200 | 000 |
| 07540281000014 | K191200 | 000 |
| 07540281000021 | K191200 | 000 |
| 07540281000175 | K191200 | 000 |
| 07540281000168 | K191200 | 000 |
| 07540281000151 | K191200 | 000 |
| 07540281000113 | K191200 | 000 |
| 07540281000106 | K191200 | 000 |
| 07540281000090 | K191200 | 000 |
| 07540281000083 | K191200 | 000 |
| 07540281000076 | K191200 | 000 |
| 07540281000069 | K191200 | 000 |
| 07540281000052 | K191200 | 000 |
| 07540281000045 | K191200 | 000 |
| 07540281000038 | K191200 | 000 |
| 07540281001547 | K191200 | 000 |