Last synced on 27 January 2023 at 11:04 pm

Brain Stimulation Programming Planning Software.

Page Type
Product Code
Definition
The brain stimulation programming planning software is a prescription device intended to assist in planning stimulation programming for implanted brain stimulators.
Physical State
Software
Technical Method
Software to display modeled stimulation field in the brain.
Target Area
Brain
Regulation Medical Specialty
Neurology
Review Panel
Neurology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
882.5855
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

Product code QQC is linked to regulation 21CFR882.5855, which does not seem to exist yet. It may be pending at the moment.

Brain Stimulation Programming Planning Software.

Page Type
Product Code
Definition
The brain stimulation programming planning software is a prescription device intended to assist in planning stimulation programming for implanted brain stimulators.
Physical State
Software
Technical Method
Software to display modeled stimulation field in the brain.
Target Area
Brain
Regulation Medical Specialty
Neurology
Review Panel
Neurology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
882.5855
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

Product code QQC is linked to regulation 21CFR882.5855, which does not seem to exist yet. It may be pending at the moment.