510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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SEMClass II

Sub-Scalp Implanted Electroencephalogram System For Remote Patient Monitoring

21 CFR 882.1360 / Neurology
FDA source (opens on fda.gov)

SEM is the FDA product code for Sub-Scalp Implanted Electroencephalogram System For Remote Patient Monitoring, a class II device type, regulated under 21 CFR 882.1360. FDA's definition for this code reads: "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...". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
SEM
Device name
Sub-Scalp Implanted Electroencephalogram System For Remote Patient Monitoring
FDA 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.
Regulation
21 CFR 882.1360
Device class
Class II
Review panel
Neurology
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code SEM

By decision year
2 clearances under product code SEM with a decision year between 2025 and 2026, 2025 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code SEM by decision year
YearClearances
20251
20261

Applicants with the most clearances

Product code SEM
Applicants holding the most 510(k) clearances under product code SEM
ApplicantClearances
Epi-Minder Pty, Ltd.1
Uneeg Medical A/S1

Companies listing this code with FDA

Companies whose registered establishments list this code