Device class
Class II
Regulation 882.1400
Total clearances
7
2020-02-20 → 2026-03-20
Definition
What is Standard Polysomnograph With Electroencephalograph
Acquire, display, store, and archive electroencephalographic signals from the brain and other signals (such as electromyography, respiratory and/or oximetry signals) for sleep recordings. May also be used to allow on-screen review, user-controlled annotation and user-controlled marking of data.
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 |
| 95808 |
CPT
|
— |
High
|
Polysomnography with EEG; standard code for comprehensive sleep study with electroencephalographic monitoring |
| 95810 |
CPT
|
— |
Medium
|
Polysomnography with EEG and additional physiologic signals (EMG, respiration, oximetry) |
Pulse
Most recent 510(k) clearances