The following data is part of a premarket notification filed by Fiberoptic Sensor Technlogies, Inc. with the FDA for Uro-pro 2000.
| Device ID | K922476 |
| 510k Number | K922476 |
| Device Name: | URO-PRO 2000 |
| Classification | Cystometric Gas (carbon-dioxide) On Hydraulic Device |
| Applicant | FIBEROPTIC SENSOR TECHNLOGIES, INC. 501 AVIS DR. Ann Arbor, MI 48108 |
| Contact | Douglas G Tomasko |
| Correspondent | Douglas G Tomasko FIBEROPTIC SENSOR TECHNLOGIES, INC. 501 AVIS DR. Ann Arbor, MI 48108 |
| Product Code | FAP |
| CFR Regulation Number | 876.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-26 |
| Decision Date | 1993-07-20 |