DISPOSABLE ECG ELECTRODES EASATRACE— 510(k) K850085

Substantially Equivalent

Medical Device Marketing

FDA 510(k) clearance K850085 for DISPOSABLE ECG ELECTRODES EASATRACE, Substantially Equivalent on 1985-02-27. Applicant: Medical Device Marketing.

Clearance details

Applicant: Medical Device Marketing
Product code: Code DRX
Advisory panel: Cardiovascular
Date received: 1985-01-11
Decision date: 1985-02-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walnut Creek, CA, 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.