EKGCARD SYSTEM— 510(k) K030535

Substantially Equivalent

Qrs Diagnostic, LLC

FDA 510(k) clearance K030535 for EKGCARD SYSTEM, Substantially Equivalent on 2003-06-11. Applicant: Qrs Diagnostic, LLC.

Clearance details

Applicant: Qrs Diagnostic, LLC
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 2003-02-20
Decision date: 2003-06-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plymouth, MN, 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.