Last synced on 2 December 2022 at 11:04 pm

Continuous Ventilator

Page Type
Product Code
Definition
Intended to provide continuous ventilatory support for use during declared public health emergency. May be used in hospital or facility settings.
Physical State
n/a
Technical Method
n/a
Target Area
n/a
Review Panel
Ear, Nose, Throat
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 QOS is assigned to devices that are "not-classified", it is not linked to any specific regulation and CFR section.

Continuous Ventilator

Page Type
Product Code
Definition
Intended to provide continuous ventilatory support for use during declared public health emergency. May be used in hospital or facility settings.
Physical State
n/a
Technical Method
n/a
Target Area
n/a
Review Panel
Ear, Nose, Throat
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 QOS is assigned to devices that are "not-classified", it is not linked to any specific regulation and CFR section.