Continuous Ventilator, Minimal Ventilatory Support
QOR · Not classified · Unknown
Classification
FDA Product Code
QOR
Device class
Not classified
Regulation
—
Review panel
AN
Medical specialty
Unknown
Submission type
8
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
A continuous ventilator (respirator) for emergency use that is intended to provide minimal ventilatory support to mechanically control or assist patient breathing during declared public health emergency.