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Non-Normalizing Quantitative Electroencephalograph Software

Page Type
Product Code
Definition
Analyze electroencephalograph data using conventional methodology to output and display standard electroencephalograph parameters for interpretation by a qualified user.
Physical State
Electroencephalograph analysis software. Does NOT include electrodes, amplitude-integrated electroencephalograph, automatic event-detection software, software that compares data to a database (normal or otherwise) or electroencephalograph software that outputs an index, classification, diagnosis, or any clinical interpretation of the data.
Technical Method
Uses software algorithms as a tool to analyze electroencephalograph (from user-specified electrode number and locations) and automatically calculate conventional electroencephalograph parameters. (e.g. spectral edge frequency, total power, percent alpha, asymmetry).
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).

Non-Normalizing Quantitative Electroencephalograph Software

Page Type
Product Code
Definition
Analyze electroencephalograph data using conventional methodology to output and display standard electroencephalograph parameters for interpretation by a qualified user.
Physical State
Electroencephalograph analysis software. Does NOT include electrodes, amplitude-integrated electroencephalograph, automatic event-detection software, software that compares data to a database (normal or otherwise) or electroencephalograph software that outputs an index, classification, diagnosis, or any clinical interpretation of the data.
Technical Method
Uses software algorithms as a tool to analyze electroencephalograph (from user-specified electrode number and locations) and automatically calculate conventional electroencephalograph parameters. (e.g. spectral edge frequency, total power, percent alpha, asymmetry).
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).