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Mechanical Ventilator

FDA product code ONZ · 5 cleared devices

Class 2 Anesthesiology
Regulation
21 CFR 868.5895
Review panel
AN
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2009-07-20 – 2016-12-02

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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