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510(k) Data Aggregation

    K Number
    K132172
    Device Name
    NEONATALIE RESUSCITATOR
    Manufacturer
    LAERDAL MEDICAL A/S
    Date Cleared
    2015-01-15

    (549 days)

    Product Code
    BTM
    Regulation Number
    868.5915
    Why did this record match?
    Applicant Name (Manufacturer) :

    LAERDAL MEDICAL A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NeoNatalie Resuscitator is a self-inflating, manual resuscitator intended for newborns and infants up to 5 kg body mass who require respiratory support.
    Device Description
    The NeoNatalie Resuscitator is a self-inflating, manual resuscitator intended for newborns and infants up to 5 kg body mass who require respiratory support. A manual resuscitator is a resuscitation device in which ventilation of the lungs is produced by the operator compressing the compressible unit of the device, the ventilation bag. The ventilation bag is self-inflating: the compressed bag will refill with ambient air via the bag inlet valve. The resuscitator provides positive pressure ventilation of the lungs (when used with a face mask). The resuscitator can be used to provide supplemental oxygen when used with the oxygen kit, the NeoNatalie Resuscitator Oxygen Kit. When a resuscitator fitted with an oxygen reservoir is used to provide supplemental oxygen, the ventilation bag will refill with oxygen from the oxygen reservoir. The NeoNatalie Resuscitator is made of polysulfone, silicone rubber and stainless steel. The NeoNatalie Resuscitator is reusable resuscitator which may be sterilized by autoclaving.
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    K Number
    K122050
    Device Name
    CPRMETER CPR FEEDBACK DEVICE
    Manufacturer
    LAERDAL MEDICAL A/S
    Date Cleared
    2012-10-22

    (102 days)

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

    LAERDAL MEDICAL A/S

    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 CPRmeter™ device is small, lightweight (approximately the size and weight of a cell phone), and powered by a replaceable battery. The CPRmeter device is intended for use by responders who have been trained in CPR and use of the CPRmeter device. If in doubt about the appropriateness for use or ability to use. CPR is to be performed without using the CPRmeter device. When attached to the bare chest of a suspected SCA victim, the CPRmeter device 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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    K Number
    K023805
    Device Name
    LAERDAL PAEDIATRIC POCKET MASK, MODEL 820050
    Manufacturer
    LAERDAL MEDICAL A/S
    Date Cleared
    2003-02-11

    (89 days)

    Product Code
    CBP
    Regulation Number
    868.5870
    Why did this record match?
    Applicant Name (Manufacturer) :

    LAERDAL MEDICAL A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K993668
    Device Name
    LAERDAL SUCTION UNIT,(4000) MODEL 78 00 20
    Manufacturer
    LAERDAL MEDICAL A/S
    Date Cleared
    1999-12-20

    (49 days)

    Product Code
    BTA
    Regulation Number
    878.4780
    Why did this record match?
    Applicant Name (Manufacturer) :

    LAERDAL MEDICAL A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Indications for use are identical for the predicate products cited, and also more than 20 others sold in the US market, i.e., to remove obstructing secretions, blood or vomits from a patient's airway, to keep air passages to lungs open to allow ventilation.
    Device Description
    The 1999 device (LSU4000) is a new more modern, unique solid design witch added benefits of more user-friendly controls, a batery level indicator, and a built in AC adapter. LSU performance is virtually the same as for its predicate designs and configurations. Components: The subject LSU consists of a high-speed piston pump powered directly by an electric motor, an internal 12 V sealed lead-acid rechargeable battery, an electronic circuit board with controls and signalling light-emitting diodes. All components are assembled into a custom plastic cabinet. The 12 V battery and 8,4 V motor make it possible to both operate and charge the unit from any 12 - 28 VDC, 4 Amp source. Charging may also take place utilizing the internal 110-230 VAC power adapter.
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