← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

OMC — 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

DEVICE CLASS
Class II
REGULATION
21 CFR 882.1400
MEDICAL SPECIALTY
Neurology
REVIEW PANEL
NE
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
6
510(K)/PMA CLEARANCES
510k: 6
0
RECALL ENTRIES

Recent clearances

K261101Ceribell, Inc. · 510k2026-06-30
K251550Naox Technologies Sas · 510k2025-11-25
K251726Forest Devices, Inc. · 510k2025-09-03
K243185Epitel · 510k2025-03-21
K242930Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) · 510k2024-11-19
K232779Qx World, Ltd. · 510k2024-10-11

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →