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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device mechanical ventilator
Regulation Description Continuous ventilator.
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,
Product CodeONZ
Regulation Number 868.5895
Device Class 2


Premarket Reviews
ManufacturerDecision
NEW AERA, INC.
  SUBSTANTIALLY EQUIVALENT 1


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