Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K240162
    Device Name
    LIFEPAK® 35 AC Power Adapter (41335-000001)
    Manufacturer
    Stryker Physio-Control
    Date Cleared
    2024-04-19

    (88 days)

    Product Code
    MPD
    Regulation Number
    870.5300
    Why did this record match?
    Product Code :

    MPD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LIFEPAK 35 AC power adapter is an optional accessory intended to connect to the LIFEPAK 35 monitor/defibrillator to provide auxiliary power. The bracket and screws provided are intended to attach the power adapter to a wall or shelf. The LIFEPAK 35 AC power adapter is intended for indoor environments and for fixed installation in ground transportation vehicles.
    Device Description
    The LIFEPAK 35 AC Power Adapter is an optional accessory for use with only the LIFEPAK 35 monitor/defibrillator. This accessory contains: AC power adapter with output cable, mounting bracket, bracket screws, region-specific AC power cord (packed separately). The power adapter: - Provides operating power to the monitor/defibrillator without batteries installed. - Provides power to charge batteries installed in the monitor/ defibrillator. The LIFEPAK 35 AC Power Adapter operates on 100 to 240 VAC line power. Installed batteries are charged whenever the power adapter is connected to the LIFEPAK 35 monitor/defibrillator. To help manage and maintain battery charge, the power adapter should be kept plugged into the defibrillator whenever possible.
    Ask a Question
    K Number
    K062331
    Device Name
    HIGHPAK-12
    Manufacturer
    AD ELEKTRONIK GMBH
    Date Cleared
    2007-07-10

    (334 days)

    Product Code
    MPD
    Regulation Number
    870.5300
    Why did this record match?
    Product Code :

    MPD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HighPak® -12 rechargeable lithium battery is intended for use in the LifePak-12 defibrillator.
    Device Description
    The HighPak -2 is a lithium manganese rechargeable battery. The outer case is molded plastic and is identical in shape and size to the predicate LifePak-12 NiCd battery. The lithium manganese cell technology offers the same voltage but an increased in amp hours resulting in longer life. It is charged in the same manner as the predicate battery and is "Smart Battery" system compatible.
    Ask a Question

    Page 1 of 1