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510(k) Data Aggregation
K Number
K132172Device Name
NEONATALIE RESUSCITATOR
Manufacturer
LAERDAL MEDICAL A/S
Date Cleared
2015-01-15
(549 days)
Product Code
BTM
Regulation Number
868.5915Why 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
K122050Device Name
CPRMETER CPR FEEDBACK DEVICE
Manufacturer
LAERDAL MEDICAL A/S
Date Cleared
2012-10-22
(102 days)
Product Code
LIX
Regulation Number
870.5210Why 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
K023805Device Name
LAERDAL PAEDIATRIC POCKET MASK, MODEL 820050
Manufacturer
LAERDAL MEDICAL A/S
Date Cleared
2003-02-11
(89 days)
Product Code
CBP
Regulation Number
868.5870Why 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
K993668Device 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
878.4780Why 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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