Sub-Scalp Implanted Electroencephalogram System For Remote Patient Monitoring
A sub-scalp implanted electroencephalogram (EEG) system for remote patient monitoring is a prescription neurological device used to continuously acquire, transmit, and store electrical brain activity in patients with epilepsy via sub-scalp implanted electrodes connected to a transmitter or storage device, enabling remote clinician monitoring of brain activity between visits; it is not intended to be implanted in brain tissue. It is classified as FDA Class II (510(k) required) under regulation 882.1360 in the Neurology specialty, with product code SEM. The device is flagged as an implant due to the sub-scalp electrode placement, but does not support life-sustaining functions.
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Basic Information
- Product Code
- SEM
- Device Class
- FDA class 2
- Regulation Number
- 882.1360
- Medical Specialty
- Neurology
- Review Panel
- NE
- Submission Type
- 1
Device Characteristics
Definition
A sub-scalp implanted electroencephalogram (EEG) system for remote patient monitoring is a prescription device used for continuously acquiring, transmitting, and storing electrical brain activity of patients with epilepsy. The device consists of sub-scalp implanted electrodes that are connected to a transmitter or storage device. The device is used to aid clinicians in the remote monitoring of electrical activity in the patients brain. The device is not intended to be implanted in brain tissue.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.