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510(k) Data Aggregation
K Number
K062119Device Name
HLR MODEL 601 HEART LUNG RESUSCITATOR AND HEARTSAVER 100
Manufacturer
Date Cleared
2006-09-22
(59 days)
Product Code
Regulation Number
870.5200Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL PRODUCTS MFG., LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The HLR™ Model-601 Heart Lung Resuscitator and the HeartSaver 100 are intended to be used as adjuncts to manual CPR on patients in cardiac arrest. The HLR Model-601 and the HeartSaver 100 are designed for use on adults or large children and should be administered by trained medical personnel.
The HLR™ Model-601 Heart Lung Resuscitator and the HeartSaver 100 are intended for use as adjuncts to manual CPR on patients who are non-breathing, unconscious, pulseless and in urgent need of cardiopulmonary resuscitation.
Device Description
HLR Model-601 Heart Lung Resuscitator and the HeartSaver 100 are modifications to the pre-Amendment HLR® PARA-MED™ Heart Lung Resuscitator. The HLR Model-601 and the HeartSaver 100 are compact, totally portable, automatic CPR Devices. The HLR Model-601 and the HeartSaver 100 are air-powered medical devices used for emergency resuscitation of patients who have stopped spontaneous breathing. The HLR Model-601 and the HeartSaver 100 provide automatic chest compressions and ventilation per the current American Heart Association Guidelines. The devices can control the depth of chest compressions and the volume of ventilation. The HLR Model-601 and the HeartSaver 100 allow the trained user three options of compression to ventilation ratios (30:2), (15:2) and continuous chest compressions without ventilation.
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