BLOOD PRESSURE MONITOR, MODEL M100— 510(k) K032308

Substantially Equivalent

Meditek Technology, Inc.

FDA 510(k) clearance K032308 for BLOOD PRESSURE MONITOR, MODEL M100, Substantially Equivalent on 2003-11-10. Applicant: Meditek Technology, Inc..

Clearance details

Applicant: Meditek Technology, Inc.
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2003-07-25
Decision date: 2003-11-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pei Tun Dist., Taichung, 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.