FINOMETER MODEL-2 WITH ACCESSORIES— 510(k) K063111

Substantially Equivalent

Finapres Medical Systems B.V.

FDA 510(k) clearance K063111 for FINOMETER MODEL-2 WITH ACCESSORIES, Substantially Equivalent on 2007-02-01. Applicant: Finapres Medical Systems B.V..

Clearance details

Applicant: Finapres Medical Systems B.V.
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2006-10-11
Decision date: 2007-02-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Amsterdam Zo, NL

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.