The following data is part of a premarket notification filed by Fiberoptic Sensor Technlogies, Inc. with the FDA for Fst Cath Ud-dual Dual Pressure Catheter.
Device ID | K926088 |
510k Number | K926088 |
Device Name: | FST CATH UD-DUAL DUAL PRESSURE CATHETER |
Classification | Device, Cystometric, Hydraulic |
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 | FEN |
CFR Regulation Number | 876.1620 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-12-02 |
Decision Date | 1993-06-18 |