ONZ · Class II · 21 CFR 868.5895

FDA Product Code ONZ: Mechanical Ventilator

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,

6
Total
6
Cleared
208d
Avg days
2009
Since

FDA 510(k) Cleared Mechanical Ventilator Devices (Product Code ONZ)

6 devices
1–6 of 6
No devices found for this product code.

About Product Code ONZ - Regulatory Context