FDA 510(k)

DEFIBTECH ELECTRODE ADAPTER, MODEL DAC-300 SERIES

K-Number: K033144 · 2003-11-13

Decision Date2003-11-13

Product CodeMKJ

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

DEFIBTECH ELECTRODE ADAPTER, MODEL DAC-300 SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Defibtech, LLC. It received FDA 510(k) clearance on 2003-11-13 under 510(k) number K033144. 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 DEFIBTECH ELECTRODE ADAPTER, MODEL DAC-300 SERIES?

DEFIBTECH ELECTRODE ADAPTER, MODEL DAC-300 SERIES is a medical device that received FDA 510(k) clearance on 2003-11-13. The listed applicant is Defibtech, LLC. The 510(k) number is K033144.

When did DEFIBTECH ELECTRODE ADAPTER, MODEL DAC-300 SERIES receive FDA 510(k) clearance?

DEFIBTECH ELECTRODE ADAPTER, MODEL DAC-300 SERIES received FDA 510(k) clearance on 2003-11-13, under 510(k) number K033144.

Who is the listed applicant for DEFIBTECH ELECTRODE ADAPTER, MODEL DAC-300 SERIES?

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 DEFIBTECH ELECTRODE ADAPTER, MODEL DAC-300 SERIES?

The FDA product code for DEFIBTECH ELECTRODE ADAPTER, MODEL DAC-300 SERIES is MKJ. This falls under the Dental category.

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Other records listing Defibtech, LLC as applicant

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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.