Device class
Class II
Regulation 882.1835
Total clearances
11
2020-12-27 → 2025-03-12
Classification details
Medical specialty
Neurology
Regulation number
882.1835
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Eb Neuro S.P.A. |
2 |
0 |
2024-12-12 |
|
X-Trodes |
1 |
0 |
2024-02-04 |
|
Blackrock Microsystems |
1 |
0 |
2021-02-10 |
|
Quantalx Neroscience |
1 |
0 |
2025-03-12 |
|
Brainmatterz, LLC |
1 |
0 |
2023-06-01 |
|
Somnomed Technologies Inc., Doing Business AS Remware |
1 |
0 |
2024-09-04 |
|
Hipposcreen Neurotech Corp. |
1 |
0 |
2020-12-27 |
|
Dormotech Medical, Ltd. |
1 |
0 |
2023-10-11 |
|
Cgx, LLC |
1 |
0 |
2021-05-20 |
|
Neurotronics, Inc. |
1 |
0 |
2022-07-15 |
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 |
| 95800 |
CPT
|
— |
Medium
|
CPT code for electroencephalography (EEG) and related physiological signal amplification procedures |
| 95925 |
CPT
|
— |
Medium
|
CPT code for short latency somatosensory evoked potentials requiring signal amplification |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2025-03-12 |
K243746 |
Quantalx Neroscience
|
Delphi Amplifier |
| 2024-12-12 |
K242832 |
Eb Neuro S.P.A.
|
NExT Station; NExT Station Advanced |
| 2024-09-04 |
K242305 |
Eb Neuro S.P.A.
|
BE Plus PRO, Neurotravel LIGHT |
| 2024-09-04 |
K240646 |
Somnomed Technologies Inc., Doing Business AS Remware
|
DreamClear |
| 2024-02-04 |
K232210 |
X-Trodes
|
X-trodes System M |
| 2023-10-11 |
K230148 |
Dormotech Medical, Ltd.
|
Vlab |
| 2023-06-01 |
K223676 |
Brainmatterz, LLC
|
SomniCheck |
| 2022-07-15 |
K220631 |
Neurotronics, Inc.
|
NomadAir PMU810 |
| 2021-05-20 |
K203331 |
Cgx, LLC
|
Quick-20m |
| 2021-02-10 |
K202174 |
Blackrock Microsystems
|
Digital NeuroPort Biopotential Signal Processing System |
| 2020-12-27 |
K201747 |
Hipposcreen Neurotech Corp.
|
8-CH Electroencephalography Amplifier |