5000 SERIES ECG ELECTRODES— 510(k) K854757

Substantially Equivalent

Alternative Design Systems, Inc.

FDA 510(k) clearance K854757 for 5000 SERIES ECG ELECTRODES, Substantially Equivalent on 1986-04-23. Applicant: Alternative Design Systems, Inc..

Clearance details

Applicant: Alternative Design Systems, Inc.
Product code: Code DRX
Advisory panel: Cardiovascular
Date received: 1985-11-27
Decision date: 1986-04-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlstadt, NJ, 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.