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510(k) K131383

X10 HEADSET WITH X-SERIES BASIC SOFTWARE, X24 HEADSET WITH X-SERIES BASIC SOFTWARE by Advanced Brain Monitoring, Inc. — Product Code GWQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 27, 2013
Date Received
May 14, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Full-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 full montage array (i.e., 16 or more electrodes) and user-specified locations

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)
  • 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)

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