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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device sub-scalp implanted electroencephalogram system for remote patient monitoring
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.
Product CodeSEM
Regulation Number 882.1360
Device Class 2


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EPI-MINDER PTY LTD
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