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6 FDA 510(k) clearances · Product code

FDA profile

Official device name

Mechanical Ventilator

Device class

Class II (moderate risk)

Regulation

21 CFR 868.5895

Medical specialty

Anesthesiology

FDA definition

This device is a volume assist ventilator intended to aid adult patients with respiratory insufficiency. It is designed for patients who are capable of spontaneously breathing a minimum tidal volume of 3.5cc/kg of predicted body weight. The device is designed for continuous applications such as patient ambulation, physical therapy, occupational therapy, respiratory therapy, and other rehabilitation efforts in an institutional or home care environment. The device is intended for operation by trained personnel, patients or caregiver under the direction of a physician,

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