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510(k) Data Aggregation

    K Number
    K232111
    Device Name
    NeoBeat, NeoBeat Mini
    Manufacturer
    Laerdal Medical AS
    Date Cleared
    2024-06-25

    (347 days)

    Product Code
    MWI
    Regulation Number
    870.2300
    Why did this record match?
    Applicant Name (Manufacturer) :

    Laerdal Medical AS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    NeoBeat and NeoBeat Mini are indicated to continuously measure and display the heart rate of neonates using dry electrodes on the torso during transition, stabilization and/or resuscitation. The devices are intended to be used in healthcare facilities. NeoBeat is intended for use on newborns approximately 1.5-5 kg. NeoBeat Mini is intended for newborns approximately 0.5-2 kg.
    Device Description
    The NeoBeat Newborn Heart Rate Meter is a battery-powered device placed on the torso of a newborn, indicated to measure the heart rate. NeoBeat does not store, display or output an ECG signal. The device is placed around the torso of the neonate such that the ECG dry electrodes contact the neonate's skin. It can be oriented caudally or cranially. In normal operation, the LED display presents the heart rate in large numerals. The display can also present other information, such as signal quality and error codes. The device comes with a charging stand.
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    K Number
    K183348
    Device Name
    Reusable Silicone Cover CPRmeter 2
    Manufacturer
    Laerdal Medical AS
    Date Cleared
    2018-12-17

    (14 days)

    Product Code
    LIX
    Regulation Number
    870.5210
    Why did this record match?
    Applicant Name (Manufacturer) :

    Laerdal Medical AS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CPRmeter 2 CPR Feedback Device is used as a guide in administering cardiopulmonary resuscitation (CPR) to a suspected sudden cardiac arrest (SCA) victim at least 8 years old.
    Device Description
    The CPRmeter 2 is used as a guide in administering CPR to a suspected sudden cardiac arrest (SCA) victim at least 8 years old. The housing material of the CPRmeter 2 is composed of polycarbonate. It is small, lightweight, and powered by a replaceable battery. The device is approximately 153 mm × 64 mm × 25 mm (6.0" × 2.5" × 1.0") and weighs approximately 191 g (6.7 oz) excluding batteries. The device is approximately the size and weight of a cell phone. It is intended to be placed between the responder's hands and the patient's chest during CPR. The CPRmeter 2 is intended for use by responders who have been trained in CPR and use of the CPRmeter 2. When placed on the bare chest of a suspected SCA victim, the CPRmeter 2 provides real-time feedback on CPR compressions in accordance with current CPR guidelines. It displays CPR feedback indicators for depth, rate, and release of chest compressions. It also counts the number of compressions in a series and provides notification of lack of expected CPR activity. The Silicone Cover is an optional accessory to the CPRmeter 2 that is designed to cover the patient contacting side of the CPRmeter 2 and provide a larger patient-contact area during use. The Silicone Cover does not require a patient adhesive.
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    K Number
    K173886
    Device Name
    CPRmeter 2 CPR Feedback Device
    Manufacturer
    Laerdal Medical AS
    Date Cleared
    2018-03-23

    (92 days)

    Product Code
    LIX
    Regulation Number
    870.5210
    Why did this record match?
    Applicant Name (Manufacturer) :

    Laerdal Medical AS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CPRmeter™ 2 CPR Feedback Device is used as a guide in administering cardiopulmonary resuscitation (CPR) to a suspected sudden cardiac arrest (SCA) victim at least 8 years old.
    Device Description
    The CPRmeter™ 2 is used as a guide in administering CPR to a suspected sudden cardiac arrest (SCA) victim at least 8 years old. The housing material of the CPRmeter™ 2 is composed of polycarbonate. It is small, lightweight and powered by a replaceable battery. The device is approximately 153 mm × 64 mm × 25 mm (6"× 2 ½"× 1") and weighs approximately 163 g (5.7 oz), excluding batteries. The device is approximately the size and weight of a cell phone. It is intended to be placed between the responder's hands and the patient's chest during CPR by means of a self-adhesive foam pad. The CPRmeter™ 2 is intended to be used by responders who have been trained in CPR and use of the CPRmeter™ 2. If the responder is in doubt about its appropriateness for use or the ability to use it. CPR is to be performed without using the CPRmeter™ 2 device. When placed on the bare chest of a suspected SCA victim, the CPRmeter™ 2 provides real-time feedback on CPR compressions in accordance with current CPR guidelines. It displays CPR feedback indicators for depth, rate, and release of chest compressions. It also counts the number of compressions in a series and provides notification of lack of expected CPR activity. The CPRmeter™ 2 may be reused, provided proper cleaning procedures are performed after each patient use.
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    K Number
    K151702
    Device Name
    Reusable Full Silicone Cover
    Manufacturer
    LAERDAL MEDICAL AS
    Date Cleared
    2015-08-13

    (50 days)

    Product Code
    LIX
    Regulation Number
    870.5210
    Why did this record match?
    Applicant Name (Manufacturer) :

    LAERDAL MEDICAL AS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CPRmeter™ is used as a guide in administering cardiopulmonary resuscitation (CPR) to a suspected sudden cardiac arrest (SCA) victim at least 8 years old.
    Device Description
    The Modified Cover is an optional accessory to the CPRmeter™ that is designed to cover the patient contacting side of the CPRmeter™ and provide a larger patient-contact area during use and does not require a patient adhesive. The CPRmeter™ is small, lightweight, and powered by a replaceable battery. The device is approximately 154 mm × 28 mm (6" × 2½" × 1″) and weighs approximately 227 grams (8 ounces) - approximately the size and weight of a cell phone. It is intended to be placed between the responder's hands and the patient's chest during CPR. The CPRmeter™ is intended for use by responders who have been trained in CPR and use of the CPRmeter™. The CPRmeter™ is used as a guide in administering CPR to a suspected sudden cardiac arrest (SCA) victim at least 8 years old. When placed on the bare chest of a suspected SCA victim, the CPRmeter™ provides real-time feedback on CPR compressions in accordance with current CPR guidelines. It displays CPR feedback indicators for depth, rate, and release of chest compressions. It also counts the number of compressions in a series and provides notification of lack of expected CPR activity.
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