Last synced on 30 September 2022 at 11:05 pm

Magnetoencephalograph

Page Type
Product Code
Definition
Acquire, display, store, and archive biomagnetic signals produced by electrically active nerve tissue in the brain to provide information about the location of active nerve tissue responsible for certain brain functions relative to brain anatomy.
Physical State
Magnetoencephalograph recording device (hardware, basic software)
Technical Method
Uses a helmet with sensors to record the magnetic 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).

Magnetoencephalograph

Page Type
Product Code
Definition
Acquire, display, store, and archive biomagnetic signals produced by electrically active nerve tissue in the brain to provide information about the location of active nerve tissue responsible for certain brain functions relative to brain anatomy.
Physical State
Magnetoencephalograph recording device (hardware, basic software)
Technical Method
Uses a helmet with sensors to record the magnetic 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).