EIKON AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-200M/HD-200— 510(k) K021240

Substantially Equivalent

Eikon Healthcare Device Corp.

FDA 510(k) clearance K021240 for EIKON AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-200M/HD-200, Substantially Equivalent on 2002-11-08. Applicant: Eikon Healthcare Device Corp..

Clearance details

Applicant: Eikon Healthcare Device Corp.
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2002-04-18
Decision date: 2002-11-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hsin-Chu City,, TW

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.