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Sub-Scalp Implanted Electroencephalogram System For Remote Patient Monitoring

Sub-Scalp Implanted Electroencephalogram System For Remote Patient Monitoring is a medical device type in the Neurology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets. This device type includes implantable products.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.

Global Registration Data
Multi-Country Intelligence
Sub-Scalp Implanted Electroencephalogram System For Remote Patient Monitoring
Neurology Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

SEM

View Product Code Classification

Class 2

21 CFR 882.1360

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Neurology

Device Characteristics

No

Yes

No

Not Eligible

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 patientย’s brain. The device is not intended to be implanted in brain tissue.