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510(k) K152040

X8 System - Sleep Profiler (SP40), X8 System - Sleep Profiler PSG2 (SP29), X8 System - Stat X8 (XS29) by Advanced Brain Monitoring, Inc. — Product Code OMC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 2015
Date Received
July 22, 2015
Clearance Type
Traditional
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)
  • 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)
  • K130013 — X4 SYSTEM (January 31, 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)