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 |