BESTSHAPE BLOOD PRESSURE MONITORING SYSTEM— 510(k) K112647

Substantially Equivalent

Wistron Corporation

FDA 510(k) clearance K112647 for BESTSHAPE BLOOD PRESSURE MONITORING SYSTEM, Substantially Equivalent on 2011-11-22. Applicant: Wistron Corporation.

Clearance details

Applicant: Wistron Corporation
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2011-09-12
Decision date: 2011-11-22
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.