K864000 is an FDA 510(k) clearance for the FST DISPOSABLE FIBER OPTIC TRANSDUCER #0100-00. This device is classified as a Transducer, Pressure, Catheter Tip (Class II - Special Controls, product code DXO).
Submitted by Fiberoptic Sensor Technlogies, Inc. (Plymouth, US). The FDA issued a Cleared decision on January 16, 1987, 94 days after receiving the submission on October 14, 1986.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2870.
| 510(k) Number | K864000 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 14, 1986 |
| Decision Date | January 16, 1987 |
| Days to Decision | 94 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DXO — Transducer, Pressure, Catheter Tip |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2870 |