LS SERIES 200 FLOVISION SYSTEM— 510(k) K971981

Substantially Equivalent

Systam

FDA 510(k) clearance K971981 for LS SERIES 200 FLOVISION SYSTEM, Substantially Equivalent on 1998-12-22. Applicant: Systam.

Clearance details

Applicant: Systam
Product code: Code CAF
Advisory panel: Anesthesiology
Date received: 1997-05-29
Decision date: 1998-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elfers, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code CAF

product code CAF

Death: 22
Injury: 125
Malfunction: 613
Other: 11
Total: 771

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.