Device class
Class II
Regulation 882.1400
Total clearances
6
2021-08-05 → 2026-08-13
Definition
What is Index-Generating Electroencephalograph Software
Analyze electrical activity of the brain by transformation of electroencephalograph signals into a dimensionless index number for use and 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 |
|
Masimo Corporation
|
2 |
1 |
2026-07-10 |
|
Cortical Dynamics , Ltd. |
1 |
0 |
2023-09-01 |
|
Covidien, LLC
|
1 |
0 |
2024-02-26 |
|
Neurowave Systems, Inc. |
1 |
0 |
2021-08-05 |
|
Covidien LP
|
1 |
1 |
2026-08-13 |
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 with algorithmic index generation output |
| 95819 |
CPT
|
— |
Medium
|
Electroencephalogram initial service; index-generating software typically billed as analysis component |
Pulse
Most recent 510(k) clearances