FORTIFIER DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL LF-01— 510(k) K041400

Substantially Equivalent

Fortifier International Co., Ltd.

FDA 510(k) clearance K041400 for FORTIFIER DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL LF-01, Substantially Equivalent on 2004-08-24. Applicant: Fortifier International Co., Ltd..

Clearance details

Applicant: Fortifier International Co., Ltd.
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2004-05-26
Decision date: 2004-08-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hsin Chu City, TW

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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.