ELECTRODE RTE-3, CLIP-ON DIAGNOSTIC ELECTRODE— 510(k) K871441

Substantially Equivalent

Nitto Denko America, Inc.

FDA 510(k) clearance K871441 for ELECTRODE RTE-3, CLIP-ON DIAGNOSTIC ELECTRODE, Substantially Equivalent on 1987-08-03. Applicant: Nitto Denko America, Inc..

Clearance details

Applicant: Nitto Denko America, Inc.
Product code: Code DRX
Advisory panel: Cardiovascular
Date received: 1987-04-13
Decision date: 1987-08-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, 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.