# Sub-Scalp Implanted Electroencephalogram System For Remote Patient Monitoring
> **Product code: SEM** · Class II — Moderate Risk (510(k) clearance required) · Neurology · 21 CFR 882.1360
## Classification
- **FDA Product Code:** SEM
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 882.1360
- **Review panel:** NE
- **Medical specialty:** Neurology
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** Y
- **Third-party review:** N
## 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 patient’s brain. The device is not intended to be implanted in brain tissue.

## Market data
- **Cleared 510(k) submissions:** 1
- **Registered establishments:** 4
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=SEM)
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