SOFT-E SERIES T-10 ACCUTRACE TAB RESTING ELECTRODE— 510(k) K881085

Substantially Equivalent

Contour Electrodes, Inc.

FDA 510(k) clearance K881085 for SOFT-E SERIES T-10 ACCUTRACE TAB RESTING ELECTRODE, Substantially Equivalent on 1988-04-11. Applicant: Contour Electrodes, Inc..

Clearance details

Applicant: Contour Electrodes, Inc.
Product code: Code DRX
Advisory panel: Cardiovascular
Date received: 1988-03-08
Decision date: 1988-04-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Herrin, IL, 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.