Device class
Class II
Regulation 882.1400
Total clearances
13
2020-10-29 → 2026-06-27
Definition
What is Automatic Event Detection Software For Polysomnograph With Electroencephalograph
Automatically mark electroencephalograph and polysomongraph signals in order to aid in identification of such events and annotation of prolonged PSG traces; Automatically calculate simple measures obtained from recorded signals (e.G. Magnitude, time, frequency and simple statistical measures of marked events); All output subject to verification by qualified user
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 |
| 95810 |
CPT
|
— |
High
|
Polysomnography with EEG and automatic event detection; standard code includes software-assisted artifact marking and event identification |
| 95811 |
CPT
|
— |
Medium
|
Polysomnography with EEG and technical component; automatic event detection software enhances technical service |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2026-06-27 |
K253390 |
Honeynaps Co., Ltd.
|
SOMNUM (SOMNUM) |
| 2026-03-08 |
K253668 |
Onera B.V.
|
Onera SleepMap (SLEEPMAP) |
| 2025-12-14 |
K250851 |
Cadwell Industries, Inc.
|
Hypnos (369054-200) |
| 2025-11-17 |
K252330 |
Nox Medical Ehf
|
DeepRESP |
| 2025-04-10 |
K250058 |
Brain Electrophysiology Laboratory Company, LLC
|
NEAT 001 |
| 2025-03-14 |
K241960 |
Nox Medical Ehf
|
DeepRESP |
| 2024-11-22 |
K242094 |
Beacon Biosignals, Inc.
|
Dreem 3S |
| 2024-03-08 |
K233438 |
Beacon Biosignals, Inc.
|
SleepStageML |
| 2023-08-18 |
K223539 |
Beacon Biosignals, Inc.
|
Dreem 3S |
| 2023-08-16 |
K223922 |
Honeynaps Co., Ltd.
|
SOMNUM (V.1.1.2.) |
| 2022-09-21 |
K221179 |
Neumetry Medical, Inc.
|
SomnoMetry |
| 2021-06-16 |
K210034 |
Ensodata, Inc.
|
EnsoSleep |
| 2020-10-29 |
K202142 |
Respironics, Inc.
|
Sleepware G3 |