HERO— 510(k) K021230

Substantially Equivalent

Medical Decision Networks

FDA 510(k) clearance K021230 for HERO, Substantially Equivalent on 2003-05-09. Applicant: Medical Decision Networks.

Clearance details

Applicant: Medical Decision Networks
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 2002-04-18
Decision date: 2003-05-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Charlottesville, VA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DPS

product code DPS

Death: 7
Total: 7

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.