DDU-2300 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES— 510(k) K081259

Name: FDA 510(k) clearance K081259
Creator: U.S. Food and Drug Administration
Published: 2009-06-15

Substantially Equivalent

Defibtech, LLC

FDA 510(k) clearance K081259 for DDU-2300 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES, Substantially Equivalent on 2009-06-15. Applicant: Defibtech, LLC. Device class: 3.

Clearance details

Applicant: Defibtech, LLC
Product code: Code MKJ
Device class: Class 3
Regulation: 21 CFR 870.5310
Advisory panel: Cardiovascular
Date received: 2008-05-02
Decision date: 2009-06-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guilford, CT, US

Download summary PDF View on FDA.gov ↗

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K150198 — CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz Gel2015-05-02
K142709 — samaritan PAD 450P2015-03-27
K133659 — HEARTSTART XL+DEFIBRILLATOR/MONITOR WITH END-TIDAL CARBON DIOXIDE MONITORING2015-01-23

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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.