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 |