The following data is part of a premarket notification filed by Invivo Corporation with the FDA for Uronav System.
| Device ID | K193403 |
| 510k Number | K193403 |
| Device Name: | UroNav System |
| Classification | System, Image Processing, Radiological |
| Applicant | Invivo Corporation 3545 SW 47th Ave Gainesville, FL 32608 |
| Contact | Kym Rupp |
| Correspondent | Prithul Bom REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2019-12-06 |
| Decision Date | 2019-12-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838091818 | K193403 | 000 |