DDU-2400/2450 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES— 510(k) K121853

Substantially Equivalent

Defibtech, LLC

FDA 510(k) clearance K121853 for DDU-2400/2450 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES, Substantially Equivalent on 2012-12-13. Applicant: Defibtech, LLC.

Clearance details

Applicant: Defibtech, LLC
Product code: Code MKJ
Advisory panel: Cardiovascular
Date received: 2012-06-25
Decision date: 2012-12-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guilford, CT, US

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Adverse events under product code MKJ

product code MKJ

Death: 961
Injury: 1,070
Malfunction: 90,719
Other: 8
Total: 92,758

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.