SensorMedics high | 合法醫療器材資訊網

3100A—ofYorbaLinda,California.Afteraseriesofacquisitions,VyaireMedical,Inc.marketedtheproductas3100A/BHFOVVentilators.Model3100( ...

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The SensorMedics High-Frequency Oscillatory Ventilator is a patented high-frequency (>150 Rf) mechanical ventilator designed and manufactured by SensorMedics Corp. of Yorba Linda, California. After a series of acquisitions, Vyaire Medical, Inc. marketed the product as 3100A/B HFOV Ventilators.[1] Model 3100 (later 3100A) received premarket approval from the United States Food and Drug Administration (FDA) in 1991 for treatment of all forms of respiratory failure in neonatal patients.[2] In 1995, it received pre-market approved for Pediatric Application with no upper weight limit for treating selected patients failing on conventional ventilation.

The 3100A model is used for infants and children under 35 kilograms (<35 kg).[3]

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