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510(k) K071230

APNEA RISK EVALUATION SYSTEM (ARES), MODEL 600 by Advanced Brain Monitoring, Inc. — Product Code MNR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 2007
Date Received
May 3, 2007
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilatory Effort Recorder
Device Class
Class II
Regulation Number
868.2375
Review Panel
AN
Submission Type

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)
  • 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)

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