ECG ELECTRODE (VARIOUS)— 510(k) K991105

Substantially Equivalent

Conmedcorp

FDA 510(k) clearance K991105 for ECG ELECTRODE (VARIOUS), Substantially Equivalent on 1999-11-26. Applicant: Conmedcorp.

Clearance details

Applicant: Conmedcorp
Product code: Code DRX
Advisory panel: Cardiovascular
Date received: 1999-04-01
Decision date: 1999-11-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Utica, NY, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DRX

product code DRX

Death: 6
Injury: 476
Other: 2
Total: 484

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.