The following data is part of a premarket notification filed by Urodynamix Technologies Ltd with the FDA for Uronirs, Model 2000.
| Device ID | K082701 |
| 510k Number | K082701 |
| Device Name: | URONIRS, MODEL 2000 |
| Classification | Device, Cystometric, Hydraulic |
| Applicant | URODYNAMIX TECHNOLOGIES LTD 1485-555 BURRARD STREET BOX 213 Vancouver Bc, CA V7x 1m9 |
| Contact | Andre Kindsvater |
| Correspondent | Andre Kindsvater URODYNAMIX TECHNOLOGIES LTD 1485-555 BURRARD STREET BOX 213 Vancouver Bc, CA V7x 1m9 |
| Product Code | FEN |
| CFR Regulation Number | 876.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-16 |
| Decision Date | 2008-12-18 |
| Summary: | summary |