Last synced on 17 May 2024 at 11:06 pm

Reduced- Montage Standard Electroencephalograph

Page Type
Product Code
Definition
Acquire, display, store, and archive electroencephalographic signals from the brain using a user-specified and/or sponsor-specified locations with a reduced array (i.e. less than < 16) of electrodes
Physical State
May include standard EEG recording hardware (e.g. headbox, cables, CPU, monitor and basic software (needed to display, store and archive EEG and allow user-only annotation and marking); does NOT include electrodes, more complex software used to analyze EEG or automatically detect events, EEG used for PSG or sleep studies, or EEG with > 16 electrodes or more electrodes.
Technical Method
Uses electrodes (less than < 16) placed on the scalp or within the brain, via user-specified and/or sponsor-specified locations, to record and display electrical activity of the brain
Target Area
Brain
Regulation Medical Specialty
Neurology
Review Panel
Neurology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
882.1400
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 882.1400 Electroencephalograph

§ 882.1400 Electroencephalograph.

(a) Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.

(b) Classification. Class II (performance standards).

Reduced- Montage Standard Electroencephalograph

Page Type
Product Code
Definition
Acquire, display, store, and archive electroencephalographic signals from the brain using a user-specified and/or sponsor-specified locations with a reduced array (i.e. less than < 16) of electrodes
Physical State
May include standard EEG recording hardware (e.g. headbox, cables, CPU, monitor and basic software (needed to display, store and archive EEG and allow user-only annotation and marking); does NOT include electrodes, more complex software used to analyze EEG or automatically detect events, EEG used for PSG or sleep studies, or EEG with > 16 electrodes or more electrodes.
Technical Method
Uses electrodes (less than < 16) placed on the scalp or within the brain, via user-specified and/or sponsor-specified locations, to record and display electrical activity of the brain
Target Area
Brain
Regulation Medical Specialty
Neurology
Review Panel
Neurology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
882.1400
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 882.1400 Electroencephalograph

§ 882.1400 Electroencephalograph.

(a) Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.

(b) Classification. Class II (performance standards).