2 results
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60ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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Monarch Airway Clearance System, Model 1000, Product Numbers: PMACS1NA (has blue tooth capability only) and PMACS1WI (has WIFI capability). The firm name on the label is Hill-Rom Services Pte. Ltd., Singapore. The Monarch Airway Clearance System, Model 1000, is intended to provide Airway Clearance Therapy and promote bronchial drainage where external manipulation of the thorax is the physicians choice of treatment. It is indicated for patients having difficulty with secretion clearance or the presence of atelectasis caused by mucus plugging.
FDA Enforcement
Class II
·Terminated·HILL-ROM MANUFACTURING, INC.·December 6, 2017
Life2000 Ventilation System, including Life2000 Ventilator and Life2000 Compressor, Model MS-01-0118 - Product Usage: use in home and institutional settings and is not intended for ambulance or air transport.
FDA Enforcement
Class II
·Terminated·Hill-Rom Manufacturing, Inc.·December 2, 2020