PREMIE DISC ECG ELECTRODE W/PREATTACHED LEAD— 510(k) K861246

Substantially Equivalent

Conmedcorp

FDA 510(k) clearance K861246 for PREMIE DISC ECG ELECTRODE W/PREATTACHED LEAD, Substantially Equivalent on 1986-08-06. Applicant: Conmedcorp.

Clearance details

Applicant: Conmedcorp
Product code: Code DRX
Advisory panel: Cardiovascular
Date received: 1986-03-27
Decision date: 1986-08-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Utica, NY, US

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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.