Device class
Class II
Regulation 882.1400
Total clearances
7
2020-01-22 → 2026-06-30
Definition
What is Non-Normalizing Quantitative Electroencephalograph Software
Analyze electroencephalograph data using conventional methodology to output and display standard electroencephalograph parameters for interpretation by a qualified user.
Classification details
Medical specialty
Neurology
Regulation number
882.1400
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
GE Healthcare Finland Oy
|
1 |
0 |
2020-01-22 |
|
Hippoclinic |
1 |
1 |
2025-12-03 |
|
Nihon Kohden Corporation
|
1 |
1 |
2025-10-09 |
|
NeuroServo, Inc. |
1 |
0 |
2024-08-23 |
|
Pascall Systems, Inc. |
1 |
0 |
2022-05-11 |
|
Neurosoft , Ltd. |
1 |
0 |
2022-11-30 |
|
Universal Brain |
1 |
1 |
2026-06-30 |
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 |
| 95957 |
CPT
|
— |
High
|
Digital analysis and interpretation of electroencephalogram; standard code for quantitative EEG analysis and software interpretation |
| 95819 |
CPT
|
— |
Medium
|
Electroencephalogram; initial service code that may include software analysis component |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2026-06-30 |
K253767 |
Universal Brain
|
UB ERP System |
| 2025-12-03 |
K251881 |
Hippoclinic
|
HippoMind (v1.0) |
| 2025-10-09 |
K251366 |
Nihon Kohden Corporation
|
EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator (LS-940A) |
| 2024-08-23 |
K240593 |
NeuroServo, Inc.
|
VEEGix EEG System |
| 2022-11-30 |
K220254 |
Neurosoft , Ltd.
|
Neuron-Spectrum-AM with Neuron-Spectrum.NET Software |
| 2022-05-11 |
K213299 |
Pascall Systems, Inc.
|
Wireless EEG System |
| 2020-01-22 |
K191322 |
GE Healthcare Finland Oy
|
E-EEGX, N-EEGX |