FLEX-E1 ECG ELECTRODE— 510(k) K820579

Substantially Equivalent

Conmedcorp

FDA 510(k) clearance K820579 for FLEX-E1 ECG ELECTRODE, Substantially Equivalent on 1982-04-14. Applicant: Conmedcorp.

Clearance details

Applicant: Conmedcorp
Product code: Code DRS
Advisory panel: Cardiovascular
Date received: 1982-03-03
Decision date: 1982-04-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dayton, OH, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DRS

product code DRS

Death: 8
Malfunction: 776
Total: 784

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.