SENTRY SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR; EXTERNAL DEFIBRILLATION PADS (ELECTRODES) DDP-100; BATTERY PACK 1200MAH— 510(k) K013896

Name: FDA 510(k) clearance K013896
Creator: U.S. Food and Drug Administration
Published: 2002-06-19

Substantially Equivalent - Subject to Tracking Reg.

Defibtech, LLC

FDA 510(k) clearance K013896 for SENTRY SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR; EXTERNAL DEFIBRILLATION PADS (ELECTRODES) DDP-100; BATTERY PACK 1200MAH, Substantially Equivalent - Subject to Tracking Reg. on 2002-06-19. Applicant: Defibtech, LLC. Device class: 3.

Clearance details

Device name as filed: SENTRY SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR; EXTERNAL DEFIBRILLATION PADS (ELECTRODES) DDP-100; BATTERY PACK 1200MAH; BA
Applicant: Defibtech, LLC
Product code: Code MKJ
Device class: Class 3
Regulation: 21 CFR 870.5310
Advisory panel: Cardiovascular
Date received: 2001-11-23
Decision date: 2002-06-19
Decision: Substantially Equivalent - Subject to Tracking Reg.
Clearance type: Traditional
Location: Guilford, CT, US

Download summary PDF View on FDA.gov ↗

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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.