The following data is part of a premarket notification filed by Fiberoptic Sensor Technlogies, Inc. with the FDA for Fst Disposable Fiber Optic Transducer #0100-00.
Device ID | K864000 |
510k Number | K864000 |
Device Name: | FST DISPOSABLE FIBER OPTIC TRANSDUCER #0100-00 |
Classification | Transducer, Pressure, Catheter Tip |
Applicant | FIBEROPTIC SENSOR TECHNLOGIES, INC. 1158 SOUTH MAIN ST. Plymouth, MI 48170 |
Contact | Stephen Shulman |
Correspondent | Stephen Shulman FIBEROPTIC SENSOR TECHNLOGIES, INC. 1158 SOUTH MAIN ST. Plymouth, MI 48170 |
Product Code | DXO |
CFR Regulation Number | 870.2870 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-10-14 |
Decision Date | 1987-01-16 |