OSTAR USB BLOOD PRESSURE MONITOR WITH SPECTRUM / P200 FOR UPPER ARM, AND M100 FOR WRIST TYPE— 510(k) K112269

Substantially Equivalent

OSTAR MEDITECH CORP.

FDA 510(k) clearance K112269 for OSTAR USB BLOOD PRESSURE MONITOR WITH SPECTRUM / P200 FOR UPPER ARM, AND M100 FOR WRIST TYPE, Substantially Equivalent on 2011-10-20. Applicant: OSTAR MEDITECH CORP..

Clearance details

Applicant: OSTAR MEDITECH CORP.
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2011-08-08
Decision date: 2011-10-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Taipei 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.