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510(k) Data Aggregation

    K Number
    K091548
    Device Name
    AMCO REPLACEMENT BATTERY FOR PHILIPS MEDICAL MODELS BT1 AND M5070A
    Manufacturer
    AMCO INTERNATIONAL MANUFACTURING & DESIGN, INC.
    Date Cleared
    2009-08-07

    (72 days)

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

    **AMCO INTERNATIONAL MANUFACTURING **& DESIGN, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 5L318 Lithium/Manganese Dioxide (Li/MnO2) AMCO battery is a disposable replacement battery pack for use in the Philips Medical / HeartStream ForeRunner AED; specifically Philips Medical battery part number BT1. This battery has a shelf life of 4 years from the date of manufacture. The AM5070 Lithium/Manganese Dioxide (Li/MnO2) AMCO battery is a disposable replacement battery pack for use in the Philips Medical / HeartStream FRx and HeartStart Home AED; specifically Philips Medical battery part number AM5070A. This battery has a shelf life of 4 years from the date of manufacture.
    Device Description
    Non-rechargeable battery packs are utilized as a primary direct current (d-c) power source or as a standby or backup d-c power source for portable as well as stationary medical equipment. These devices provide a means of supplying electrical power through chemical reaction. The energy provided depends upon the voltage and capacity rating of a particular pack and the amount of current used 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 the discharge method. These parameters are taken into account in designing such batteries. The goal is to develop battery packs that maintain capacity for as high and as long as possible under a specified range of environmental conditions.
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    K Number
    K082861
    Device Name
    AMCO REPLACEMENT BATTERY FOR POWERHEART AED, NON-RECHARGEABLE, MODEL 2L561; G3, NON-RECHARGABLE, MODEL 7L561
    Manufacturer
    AMCO INTERNATIONAL MANUFACTURING & DESIGN, INC.
    Date Cleared
    2008-11-25

    (57 days)

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

    **AMCO INTERNATIONAL MANUFACTURING **& DESIGN, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 2L561 Lithium Sulfur Dioxide (LiSO2) AMCO battery is a disposable replacement battery pack for use in the Cardiac Science PowerHeart® AED; specifically Cardiac Science Model / Part Number 9141-001. This battery has a shelf life of 4 years from the date of manufacture. The 7L877 Lithium Sulfur Dioxide (LiSO2) AMCO battery is a disposable replacement battery pack for use in the Cardiac Science PowerHeart® AED G3; specifically Cardiac Science Model / Part Number 9146-001. This battery has a shelf life of 4 years from the date of manufacture.
    Device Description
    Non-rechargeable battery packs are utilized as a primary direct current (d-c) power source or as a standby or backup d-c power source for portable as well as stationary medical equipment. These devices provide a means of supplying electrical power through chemical reaction. The energy provided depends upon the voltage and capacity rating of a particular pack and the amount of current used 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 the discharge method. These parameters are taken into account in designing such batteries. The goal is to develop battery packs that maintain capacity for as high and as long as possible under a specified range of environmental conditions.
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    K Number
    K073716
    Device Name
    LIFE+CEL OR LIFECEL BATTERY
    Manufacturer
    AMCO INTERNATIONAL MANUFACTURING & DESIGN, INC.
    Date Cleared
    2008-04-11

    (102 days)

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

    **AMCO INTERNATIONAL MANUFACTURING **& DESIGN, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 6L785 Sealed Manganese Dioxide (MnO2) life+cel (or lifecel) is a replacement disposable battery pack, for use in the Philips Medical Systems FR2 Series AED, specifically OEM Part Number M3863A. This battery pack has a shelf life of 5 years from the date of manufacture.
    Device Description
    Non-rechargeable battery packs are utilized as a primary direct current (d-c) power source or as a standby or backup d-c power source for portable as well as stationary medical equipment. The Amco 6L785 battery chemistry is Manganese Dioxide (MnO2) based and is non rechargeable.
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    K Number
    K072596
    Device Name
    LIFE+CEL OR LIFECEL BATTERY PACK, MODEL 5L500
    Manufacturer
    AMCO INTERNATIONAL MANUFACTURING & DESIGN, INC.
    Date Cleared
    2008-01-24

    (132 days)

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

    **AMCO INTERNATIONAL MANUFACTURING **& DESIGN, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 5L500 Lithium life+cel or lifecel is a replacement battery pack for the Medtronic LifePak 500 AED. Since non-rechargeable batteries and battery packs are "device specific", and are designed to operate and fit into the equipment for which they were manufactured, only qualified personnel should evaluate, test, charge, or install these devices. This battery is shipped only to customers who request a replacement battery for a particular device or to replace a competitor's replacement battery. Biomedical equipment service professionals, EMT's, etc. therefore know that the intended use is as a replacement battery. The replacement battery pack in this submission, Amco Part Number 5L500, is to be provided by prescription only.
    Device Description
    The AMCO 5L500 life+cel™ Non-rechargeable battery pack is utilized as a primary direct current (d-c) power source or as a standby or backup d-c power source for portable as well as stationary medical equipment.
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    K Number
    K071164
    Device Name
    LIFE+CEL BATTERY
    Manufacturer
    AMCO INTERNATIONAL MANUFACTURING & DESIGN, INC.
    Date Cleared
    2007-12-07

    (225 days)

    Product Code
    MHX, MOX, MOY
    Regulation Number
    870.1025
    Why did this record match?
    Applicant Name (Manufacturer) :

    **AMCO INTERNATIONAL MANUFACTURING **& DESIGN, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To power the functions of various devices for which batteries or battery packs are configured. Since rechargeable batteries and battery packs are "device specific", and are designed to operate and fit into the equipment for which they were manufactured, only qualified personnel should evaluate, test, charge, or install these devices. This battery is shipped only to customers who request a replacement battery for a particular device or to replace a competitor's replacement battery. Biomedical equipment service professionals, EMT's, etc. therefore know that the intended use is as a replacement battery. Only replacement battery 2L226 in this submission (Patient Monitor) is provided Over-the-Counter (OTC). All other replacement batteries, specifically; 5L375, 6L577, 7L991, 9L977, 9L990, and 9L998 in this submission (Defib/AED's) are provided by prescription only.
    Device Description
    Amco rechargeable and non-rechargeable battery packs are utilized as a primary direct current (d-c) power source or as a standby or backup d -c power source for portable as well as stationary medical equipment.
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