ONZ · Class II — Moderate Risk (510(k) clearance required) · Anesthesiology · 21 CFR 868.5895
Classification
FDA Product Code
ONZ
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 868.5895
Review panel
AN
Medical specialty
Anesthesiology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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,