Last synced on 24 June 2022 at 11:05 pm

Neurological Stimulation For Emergency Use

Page Type
Product Code
Definition
authorized nerve stimulation devices for respiratory assistance for use during declared public health emergency use.
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 QPR is assigned to devices that are "not-classified", it is not linked to any specific regulation and CFR section.

Neurological Stimulation For Emergency Use

Page Type
Product Code
Definition
authorized nerve stimulation devices for respiratory assistance for use during declared public health emergency use.
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 QPR is assigned to devices that are "not-classified", it is not linked to any specific regulation and CFR section.