FINOMETER NONINVASIVE HEMODYNAMIC MONITOR, MODEL 1— 510(k) K023723

Substantially Equivalent

Fms, Finapres Medical Systems BV

FDA 510(k) clearance K023723 for FINOMETER NONINVASIVE HEMODYNAMIC MONITOR, MODEL 1, Substantially Equivalent on 2003-10-23. Applicant: Fms, Finapres Medical Systems BV.

Clearance details

Applicant: Fms, Finapres Medical Systems BV
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2002-11-05
Decision date: 2003-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Barbara, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DXN

product code DXN

Death: 3
Injury: 169
Malfunction: 1,019
Other: 2
Total: 1,193

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.