FST DISPOSABLE FIBER OPTIC TRANSDUCER #0100-00
Device Facts
| Record ID | K864000 |
|---|---|
| Device Name | FST DISPOSABLE FIBER OPTIC TRANSDUCER #0100-00 |
| Applicant | Fiberoptic Sensor Technlogies, Inc. |
| Product Code | DXO · Cardiovascular |
| Decision Date | Jan 16, 1987 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.2870 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A catheter tip pressure transducer is a device incorporated into the distal end of a catheter. When placed in the bloodstream, its mechanical or electrical properties change in relation to changes in blood pressure. These changes are transmitted to accessory equipment for processing.
