Device class
Class II
Regulation 882.1400
Total clearances
18
2020-03-17 → 2026-06-13
Definition
What is Full-Montage Standard Electroencephalograph
Acquire, display, store, and archive electroencephalographic signals from the brain using a full montage array (i.e., 16 or more electrodes) and user-specified locations
Classification details
Medical specialty
Neurology
Regulation number
882.1400
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
Reimbursement
Likely billing codes (AI-inferred · verify with billing)
Healthcare providers using this device would typically bill under these HCPCS Level II
(alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku;
official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available.
Always verify with billing/coding teams before relying on these.
| Code | Type | Description | Confidence | Rationale |
| 95819 |
CPT
|
— |
High
|
Electroencephalogram (EEG); standard CPT for full-montage EEG acquisition and recording |
| 95822 |
CPT
|
— |
Medium
|
EEG with video recording; applicable if device includes video monitoring capability |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2026-06-13 |
K261604 |
Neuroelectrics Barcelona S.L.U.
|
Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32) |
| 2026-03-13 |
K260455 |
Zeto, Inc.
|
New Wave System |
| 2024-04-30 |
K233403 |
Zeto, Inc.
|
Flexset System |
| 2023-11-09 |
K231366 |
Bioserenity Sas
|
Neuronaute Plus |
| 2023-08-31 |
K221959 |
Neurofield, Inc.
|
Q21 |
| 2023-08-18 |
K231457 |
Spark Neuro, Inc.
|
SPARK Scan |
| 2023-04-27 |
K221963 |
Cumulus Neuroscience Limited
|
Cumulus Functional Neurophysiology Platform |
| 2023-02-09 |
K230073 |
Compumedics Limited
|
Okti |
| 2023-01-12 |
K223644 |
Bioserenity
|
Neuronaute with IceCap 2 & IceCap 2 Small |
| 2022-08-10 |
K220056 |
iMediSync, Inc.
|
iSyncWave |
| 2022-06-16 |
K212788 |
Seer Medical Pty, Ltd.
|
Seer Home |
| 2022-05-06 |
K213900 |
Wavi Co.
|
WAVi SCAN EEG System and Accessories |
| 2020-12-30 |
K193159 |
Corscience GmbH & Co. KG
|
NeuroAmp II, NeuroAmp II.5s |
| 2020-12-10 |
K202334 |
Bioserenity Sas
|
Neuronaute |
| 2020-09-29 |
K201819 |
Cadwell Industries, Inc.
|
Cadwell Apollo System |
| 2020-04-24 |
K191492 |
Neurovirtual USA, Inc.
|
Maxxi Position Sensor |
| 2020-03-31 |
K191868 |
Ice Neurosystems, Inc.
|
iCEWav Neuromonitoring Platform |
| 2020-03-17 |
K192753 |
Medeia, Inc.
|
NeuralScan System |