Chrysalis Intelligence · Product Codes · OMC

OMC · Reduced- Montage Standard Electroencephalograph

Neurology · 12 clearances · 9 unique sponsors

Device class
Class II
Regulation 882.1400
Total clearances
12
2020-06-22 → 2026-06-30
Last 12 months
2
Unique sponsors
9
Definition

What is Reduced- Montage Standard Electroencephalograph

Acquire, display, store, and archive electroencephalographic signals from the brain using a user-specified and/or sponsor-specified locations with a reduced array (i.e. less than < 16) of electrodes
Medical specialty
Neurology
Review panel
NE
Regulation number
882.1400
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
Y
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Epitel, Inc. 3 0 2025-03-21
Forest Devices, Inc. 2 0 2025-09-03
Neurosteer, Inc. 1 0 2022-10-24
Byteflies NV 1 0 2020-06-22
Qx World, Ltd. 1 0 2024-10-11
Ceribell, Inc. 1 1 2026-06-30
Neba Health, LLC 1 0 2023-03-02
Naox Technologies Sas 1 1 2025-11-25
Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) 1 0 2024-11-19
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.

CodeTypeDescriptionConfidenceRationale
95819 CPT — High Electroencephalogram initial service; reduced-montage EEG with fewer than 16 electrodes standard reimbursement code
95957 CPT — Medium Digital analysis and interpretation may apply if software analysis is significant component of service
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-06-30 K261101 Ceribell, Inc. Ceribell Monitor
2025-11-25 K251550 Naox Technologies Sas NX01 (NX01)
2025-09-03 K251726 Forest Devices, Inc. SignalNED System (Model RE)
2025-03-21 K243185 Epitel REMI Remote EEG Monitoring System
2024-11-19 K242930 Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) Natus BrainWatch System
2024-10-11 K232779 Qx World, Ltd. QUEX ED; QUEX S
2024-09-04 K242306 Forest Devices, Inc. SignalNED System (Model RE)
2023-06-30 K230933 Epitel, Inc. REMI Remote EEG Monitoring System
2023-03-02 K223628 Neba Health, LLC NEBA® Compact EEG2R Mobile Headset
2022-10-24 K221563 Neurosteer, Inc. Neurosteer EEG Recorder
2021-03-29 K203827 Epitel, Inc. REMI
2020-06-22 K192549 Byteflies NV Byteflies Kit