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510(k) Data Aggregation

    K Number
    K240377
    Device Name
    LIFEPAK® ECG Cables
    Manufacturer
    Stryker Physio-Control
    Date Cleared
    2024-05-07

    (90 days)

    Product Code
    DSA
    Regulation Number
    870.2900
    Why did this record match?
    Applicant Name (Manufacturer) :

    Stryker Physio-Control

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LIFEPAK ECG cables are reusable electrode cable systems intended to transmit signals from patient electrodes to the LIFEPAK monitor/defibrillator for monitoring purposes. LIFEPAK ECG cables are intended for use in outdoor and indoor emerqency care settings. LIFEPAK ECG Cables: - LIFEPAK 3-wire ECG Cable - - LIFEPAK 5-wire ECG Cable i - -LIFEPAK 4-wire ECG cable - LIFEPAK 3-wire extended precordial ECG Cable l - -LIFEPAK 6-wire expandable precordial ECG cable
    Device Description
    The LIFEPAK ECG cables are an accessory designed to be used with Physio-Control LIFEPAK 35 monitor/defibrillator. The LIFEPAK ECG cables are intended for use by Advanced Life Support (ALS) and Basic Life Support (BLS) providers to transmit signals from patient electrodes to the LIFEPAK monitor/defibrillator for monitoring purposes. The LIFEPAK ECG Cables are reusable ECG trunk cables and lead wires that connect to the LIFEPAK 35 monitor/defibrillator for ECG monitoring. There are several types or configurations of ECG cables: 3-wire, a 4-wire cable assembly to be used with the LIFEPAK 6-wire precordial cable and/or the LIFEPAK 3-wire precordial cable to perform a 12 or 15-lead ECG Cable assembly. When the LIFEPAK 4-wire ECG cable is configured with a 6-wire expandable precordial cable, a 12-lead ECG is constructed. Likewise, when the LIFEPAK 4-wire ECG cable is configured with a 6-wire expandable precordial cable and a 3-wire extended precordial ECG cable a 15-lead ECG is constructed. The 4- wire ECG cable is available in two lengths, 5 feet or 8 feet. Additionally, the 3-, 4-, and 5-wire ECG Cables and the 6-wire precordial ECG cable are available with color coding according to the American Heart Association (AHA) or International Electrotechnical Commission (IEC) standards. The LIFEPAK ECG cables are a reusable electrode cable system intended to transmit signals from patient electrodes to the LIFEPAK 35 monitor/defibrillator for both diagnostic and monitoring purposes. These accessories consist of conductor wires that are shielded and insulated by a polyurethane jacket material. The lead wires are color coded according to which electrode location they are attached to on the patient. The LIFEPAK ECG cables are not intended for use with other manufacturers' defibrillators. The LIFEPAK ECG cables are intended only for use with LIFEPAK 35 monitor/defibrillator.
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    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?
    Applicant Name (Manufacturer) :

    Stryker Physio-Control

    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.
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