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
3
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 1 2025-09-03
Neurosteer, Inc. 1 0 2022-10-24
Byteflies NV 1 0 2020-06-22
Naox Technologies Sas 1 1 2025-11-25
Ceribell, Inc. 1 1 2026-06-30
Neba Health, LLC 1 0 2023-03-02
Qx World, Ltd. 1 0 2024-10-11
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