FST DISPOSABLE FIBER OPTIC TRANSDUCER #0100-00— 510(k) K864000

Substantially Equivalent

Fiberoptic Sensor Technlogies, Inc.

FDA 510(k) clearance K864000 for FST DISPOSABLE FIBER OPTIC TRANSDUCER #0100-00, Substantially Equivalent on 1987-01-16. Applicant: Fiberoptic Sensor Technlogies, Inc..

Clearance details

Applicant: Fiberoptic Sensor Technlogies, Inc.
Product code: Code DXO
Advisory panel: Cardiovascular
Date received: 1986-10-14
Decision date: 1987-01-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plymouth, MI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DXO

product code DXO

Death: 10
Injury: 156
Malfunction: 884
Total: 1,050

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.