CARDIO TRACE ELECTRODE— 510(k) K832429

Substantially Equivalent

Poly-Med Splint Co.

FDA 510(k) clearance K832429 for CARDIO TRACE ELECTRODE, Substantially Equivalent on 1984-05-09. Applicant: Poly-Med Splint Co..

Clearance details

Applicant: Poly-Med Splint Co.
Product code: Code DRX
Advisory panel: Cardiovascular
Date received: 1983-07-22
Decision date: 1984-05-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, 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.