Last synced on 2 December 2022 at 11:04 pm

Brain Temperature Measurement System

Page Type
Product Code
Definition
A brain temperature measurement system is an externally placed, prescription device intended to measure brain temperature.
Physical State
A sensor placed on the skin surface is used to measure brain temperature. Device includes software processing to convert the raw signal into a temperature measurement for display by the device or a compatible vital signs monitor.
Technical Method
Measures brain temperature below the externally placed sensor.
Target Area
Device is used on the head to measure brain temperature.
Regulation Medical Specialty
Neurology
Review Panel
Neurology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
882.1565
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 QSL is linked to regulation 21CFR882.1565, which does not seem to exist yet. It may be pending at the moment.

Brain Temperature Measurement System

Page Type
Product Code
Definition
A brain temperature measurement system is an externally placed, prescription device intended to measure brain temperature.
Physical State
A sensor placed on the skin surface is used to measure brain temperature. Device includes software processing to convert the raw signal into a temperature measurement for display by the device or a compatible vital signs monitor.
Technical Method
Measures brain temperature below the externally placed sensor.
Target Area
Device is used on the head to measure brain temperature.
Regulation Medical Specialty
Neurology
Review Panel
Neurology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
882.1565
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 QSL is linked to regulation 21CFR882.1565, which does not seem to exist yet. It may be pending at the moment.