510(k) K130013

X4 SYSTEM by Advanced Brain Monitoring, Inc. — Product Code OMC

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: January 31, 2013
Date Received: January 2, 2013
Clearance Type: Special
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Reduced- Montage Standard Electroencephalograph
Device Class: Class II
Regulation Number: 882.1400
Review Panel: NE
Submission Type

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

Other clearances by Advanced Brain Monitoring, Inc.

K172799 — Positional Sleep Assessment System (PoSAS) software (March 9, 2018)
K153412 — Sleep Profiler (March 14, 2016)
K152040 — X8 System - Sleep Profiler (SP40), X8 System - Sleep Profiler PSG2 (SP29), X8 Sy (October 30, 2015)
K140190 — NIGHT SHIFT (May 29, 2014)
K131383 — X10 HEADSET WITH X-SERIES BASIC SOFTWARE, X24 HEADSET WITH X-SERIES BASIC SOFTWA (November 27, 2013)
K130007 — SLEEP PROFILER (April 17, 2013)
K120450 — SLEEP PROFILER (September 19, 2012)
K120447 — X4 (June 20, 2012)
K112514 — APNEA RISK EVALUATION SYSTEM (ARES) (January 9, 2012)
K111110 — APNEA GUARD (July 22, 2011)

Other clearances for product code OMC

K251550 — NX01 (NX01) (November 25, 2025)
K251726 — SignalNED System (Model RE) (September 3, 2025)
K243185 — REMI Remote EEG Monitoring System (March 21, 2025)
K242930 — Natus BrainWatch System (November 19, 2024)
K232779 — QUEX ED; QUEX S (October 11, 2024)
K242306 — SignalNED System (Model RE) (September 4, 2024)
K230933 — REMI Remote EEG Monitoring System (June 30, 2023)
K223628 — NEBA® Compact EEG2R Mobile Headset (March 2, 2023)
K221563 — Neurosteer EEG Recorder (October 24, 2022)
K203827 — REMI (March 29, 2021)