TRUVUE WIRELESS AMBULATORY ECG MONITORING SYSTEM— 510(k) K100155

Substantially Equivalent

Biomedical Systems Corp.

FDA 510(k) clearance K100155 for TRUVUE WIRELESS AMBULATORY ECG MONITORING SYSTEM, Substantially Equivalent on 2010-04-20. Applicant: Biomedical Systems Corp..

Clearance details

Applicant: Biomedical Systems Corp.
Product code: Code DSI
Advisory panel: Cardiovascular
Date received: 2010-01-20
Decision date: 2010-04-20
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: St. Louis, MO, US

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Adverse events under product code DSI

product code DSI

Death: 170
Injury: 729
Malfunction: 10,680
Total: 11,579

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.