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510(k) K140190

NIGHT SHIFT by Advanced Brain Monitoring, Inc. — Product Code MYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 29, 2014
Date Received
January 24, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pillow, Cervical (For Mild Sleep Apnea)
Device Class
Class II
Regulation Number
872.5570
Review Panel
EN
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)
  • 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 MYB

  • K180608 — Lunoa System (June 5, 2018)
  • K100160 — ZZOMA POSITIONAL SLEEPER MODEL 001 (May 11, 2010)
  • K040161 — SONA PILLOW (April 30, 2004)
  • K023010 — SNIFF POSITION PILLOWS/POPITZ PILLOWS (October 1, 2002)
  • K990871 — PILLOWPOSITIVE CERVICAL PILLOW (June 10, 1999)