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FDA 510(k)

ZOLL FULLY AUTOMATIC AED PLUS

K-Number: K120406 · 2012-10-26

ApplicantZoll Medical Corporation, World Wide Headquarters
Decision Date2012-10-26
Product CodeMKJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ZOLL FULLY AUTOMATIC AED PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Zoll Medical Corporation, World Wide Headquarters. It received FDA 510(k) clearance on 2012-10-26 under 510(k) number K120406. 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 ZOLL FULLY AUTOMATIC AED PLUS?

ZOLL FULLY AUTOMATIC AED PLUS is a medical device that received FDA 510(k) clearance on 2012-10-26. The listed applicant is Zoll Medical Corporation, World Wide Headquarters. The 510(k) number is K120406.

When did ZOLL FULLY AUTOMATIC AED PLUS receive FDA 510(k) clearance?

ZOLL FULLY AUTOMATIC AED PLUS received FDA 510(k) clearance on 2012-10-26, under 510(k) number K120406.

Who is the listed applicant for ZOLL FULLY AUTOMATIC AED PLUS?

The FDA 510(k) record lists Zoll Medical Corporation, World Wide Headquarters as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ZOLL FULLY AUTOMATIC AED PLUS?

The FDA product code for ZOLL FULLY AUTOMATIC AED PLUS is MKJ. This falls under the Dental category.

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Other records listing Zoll Medical Corporation, World Wide Headquarters as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K120907ZOLL R SERIESK112761ZOLL PROPAQ MDK112432ZOLL X SERIESK111296ZOLL RESCUENETLINKK111594ZOLL E SERIESK110361ZOLL R SERIES WITH 2010 AHA GUIDELINES SOFTWARE UPDATE

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Related Devices (Code: MKJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K131550HEART SYNCHeart Sync, Inc.K130684PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATORPhilips Medical SystemsK131494HEART 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.

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