ENVAN HEART RATE MONITOR— 510(k) K030656

Substantially Equivalent

Envan, LLC

FDA 510(k) clearance K030656 for ENVAN HEART RATE MONITOR, Substantially Equivalent on 2003-04-08. Applicant: Envan, LLC.

Clearance details

Applicant: Envan, LLC
Product code: Code DRT
Advisory panel: Cardiovascular
Date received: 2003-03-03
Decision date: 2003-04-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DRT

product code DRT

Death: 4
Total: 4

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.