MODEL #510 STEALTH-PLATE DISPERSIVE ELECTRODE— 510(k) K922064

Substantially Equivalent

Cardiotronics, Inc.

FDA 510(k) clearance K922064 for MODEL #510 STEALTH-PLATE DISPERSIVE ELECTRODE, Substantially Equivalent on 1992-12-01. Applicant: Cardiotronics, Inc..

Clearance details

Applicant: Cardiotronics, Inc.
Product code: Code GXD
Advisory panel: Neurology
Date received: 1992-05-04
Decision date: 1992-12-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Carlsbad, CA, US

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Adverse events under product code GXD

product code GXD

Injury: 228
Total: 228

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.