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510(k) Data Aggregation

    K Number
    K120350
    Device Name
    EXTENDED LIFE BATTERY
    Date Cleared
    2012-11-01

    (269 days)

    Product Code
    Regulation Number
    870.5310
    Why did this record match?
    Applicant Name (Manufacturer) :

    AED BATTERY EXCHANGE, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    To power AEDs for which the OEM battery pack was intended. Only qualified service personnel should evaluate, test, or install AED battery packs. To provide power for the specific Automated External Defibrillators (AEDs) for which the original battery packs were designed and manufactured, in back-up and portable use.
    Device Description
    The Green4Life Batteries are non-rechargeable battery packs utilized as the primary power source or as a standby or backup power source for Automated External Defibrillators (AEDs). These devices provide a means of supplying electrical power through the chemical reaction of lithium cells. The energy provided depends upon the voltage and capacity rating of a particular pack and the amount of current required by the device into which they are installed. The performance and life span of these batteries depends on operating conditions of temperature, current drain, and discharge method. The goal of these battery packs is to provide a sufficient power source for AEDs for as long as possible under a specified range of environmental conditions. The Green4Life Batteries are re-celled battery packs of those identified below in Predicate Devices.
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