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510(k) K172799

Positional Sleep Assessment System (PoSAS) software by Advanced Brain Monitoring — Product Code MNR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 9, 2018
Date Received
September 18, 2017
Clearance Type
Traditional
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

  • 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)
  • K111110 — APNEA GUARD (July 22, 2011)

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  • K252383 — Somfit D (August 28, 2025)
  • K243220 — Onera STS 2 (ONERA STS 2) (July 3, 2025)
  • K242224 — Happy Health Home Sleep Test (June 18, 2025)
  • K243092 — AcuPebble Ox (200) (March 19, 2025)
  • K243268 — TipTraQ (TTQ001) (February 3, 2025)
  • K244027 — SANSA HSAT (January 28, 2025)
  • K242290 — DormoTech NLab (January 8, 2025)