The following data is part of a premarket notification filed by Fiberoptic Sensor Technlogies, Inc. with the FDA for Fst Fiberoptic Pressure Converter.
Device ID | K945753 |
510k Number | K945753 |
Device Name: | FST FIBEROPTIC PRESSURE CONVERTER |
Classification | Device, Cystometric, Hydraulic |
Applicant | FIBEROPTIC SENSOR TECHNLOGIES, INC. 501 AVIS DR. Ann Arbor, MI 48108 |
Contact | Gary C Simpson |
Correspondent | Gary C Simpson 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 | 1994-11-23 |
Decision Date | 1995-05-11 |