VTRUST BLOOD PRESSURE MONITOR, MODEL VTRUST 701DH— 510(k) K091414

Substantially Equivalent

Biocare Corp.

FDA 510(k) clearance K091414 for VTRUST BLOOD PRESSURE MONITOR, MODEL VTRUST 701DH, Substantially Equivalent on 2009-10-21. Applicant: Biocare Corp..

Clearance details

Applicant: Biocare Corp.
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2009-05-13
Decision date: 2009-10-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taoyuan, 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.