Last synced on 12 August 2022 at 11:05 pm

Continuous Ventilator, Minimal Ventilatory Support

Page Type
Product Code
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.
Physical State
n/a
Technical Method
n/a
Target Area
n/a
Review Panel
Anesthesiology
Submission Type
EUA - Emergency Use Authorization
Device Classification
N
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

As product code QOR is assigned to devices that are "not-classified", it is not linked to any specific regulation and CFR section.

Continuous Ventilator, Minimal Ventilatory Support

Page Type
Product Code
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.
Physical State
n/a
Technical Method
n/a
Target Area
n/a
Review Panel
Anesthesiology
Submission Type
EUA - Emergency Use Authorization
Device Classification
N
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

As product code QOR is assigned to devices that are "not-classified", it is not linked to any specific regulation and CFR section.