FDA 510(k)

DDU-120 FULLY AUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES

K-Number: K113787 · 2013-01-04

Decision Date2013-01-04

Product CodeMKJ

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

DDU-120 FULLY AUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Defibtech, LLC. It received FDA 510(k) clearance on 2013-01-04 under 510(k) number K113787. The device is classified under product code MKJ. It was reviewed by the CV advisory panel. Product code MKJ falls under the category of Dental, which includes dental instruments, materials, and equipment. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DDU-120 FULLY AUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES?

DDU-120 FULLY AUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES is a medical device that received FDA 510(k) clearance on 2013-01-04. The listed applicant is Defibtech, LLC. The 510(k) number is K113787.

When did DDU-120 FULLY AUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES receive FDA 510(k) clearance?

DDU-120 FULLY AUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES received FDA 510(k) clearance on 2013-01-04, under 510(k) number K113787.

Who is the listed applicant for DDU-120 FULLY AUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES?

The FDA 510(k) record lists Defibtech, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DDU-120 FULLY AUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES?

The FDA product code for DDU-120 FULLY AUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES is MKJ. This falls under the Dental category.

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Other records listing Defibtech, LLC as applicant

K211289RMU-2000 Automated Chest Compression System K121853DDU-2400/2450 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES K081259DDU-2300 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES K033896DEFIBTECH AED WITH ATTENUATED DEFIBRILLATION/MONITORING PADS, MODELS DDU-100 WITH DDP-200P K033144DEFIBTECH ELECTRODE ADAPTER, MODEL DAC-300 SERIES K013896SENTRY SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR; EXTERNAL DEFIBRILLATION PADS (ELECTRODES) DDP-100; BATTERY PACK 1200MAH; BA

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Related Devices (Code: MKJ)

K131550HEART SYNCHeart Sync, Inc.K130684PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATORPhilips Medical Systems K131494HEART SYNCHeart Sync, Inc.K130454LIFEPAK 20 DEFIBRILLATOR/MONITOR, LIFEPAK 20E DEFIBRILLATOR/MONITORPhysio-Control, Inc.K123881HEARTSINE SAMARITAN PAD 350PHeartsine Technologies, Inc.K130153HEARSTART MRX WITH AIRWAY CONFIMRATION ASSISTPhilips Medical Systems

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.