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

Name: FDA 510(k) clearance K864000
Creator: U.S. Food and Drug Administration
Published: 1987-01-16

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.. Device class: 2.

Clearance details

Applicant: Fiberoptic Sensor Technlogies, Inc.
Product code: Code DXO
Device class: Class 2
Regulation: 21 CFR 870.2870
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 ↗

Recent devices under product code DXO

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K222216 — TruWave Disposable Pressure Transducer2022-12-22
K202943 — OptoMonitor 32020-11-24

More clearances from Fiberoptic Sensor Technlogies, Inc.

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K945753 — FST FIBEROPTIC PRESSURE CONVERTER1995-05-11
K950908 — FST CATH-UD, CATHETER1995-04-07
K945495 — 4-CHANNEL URODYNAMIC MONITOR WITH URO-FLO OPTION1995-02-09
K930171 — FST DUAL, DUAL PRESSURE URODYNAMICS MONITOR1993-11-04
K922476 — URO-PRO 20001993-07-20

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.