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FDA 510(k)

EXTENDED LIFE BATTERY

K-Number: K120350 · 2012-11-01

ApplicantAed Battery Exchange, LLC
Decision Date2012-11-01
Product CodeMKJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EXTENDED LIFE BATTERY is the device name listed in this FDA 510(k) record. The listed applicant is Aed Battery Exchange, LLC. It received FDA 510(k) clearance on 2012-11-01 under 510(k) number K120350. 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 EXTENDED LIFE BATTERY?

EXTENDED LIFE BATTERY is a medical device that received FDA 510(k) clearance on 2012-11-01. The listed applicant is Aed Battery Exchange, LLC. The 510(k) number is K120350.

When did EXTENDED LIFE BATTERY receive FDA 510(k) clearance?

EXTENDED LIFE BATTERY received FDA 510(k) clearance on 2012-11-01, under 510(k) number K120350.

Who is the listed applicant for EXTENDED LIFE BATTERY?

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

What is the FDA product code for EXTENDED LIFE BATTERY?

The FDA product code for EXTENDED LIFE BATTERY is MKJ. This falls under the Dental category.

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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

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

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