TEC-3500 DEFIBRILLATOR— 510(k) K840258

Substantially Equivalent

Nihon Kohden America, Inc.

FDA 510(k) clearance K840258 for TEC-3500 DEFIBRILLATOR, Substantially Equivalent on 1984-05-23. Applicant: Nihon Kohden America, Inc..

Clearance details

Applicant: Nihon Kohden America, Inc.
Product code: Code LDD
Advisory panel: Cardiovascular
Date received: 1984-01-23
Decision date: 1984-05-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Foothill, CA, US

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Adverse events under product code LDD

product code LDD

Death: 38
Malfunction: 522
Total: 560

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.