FDA 510(k) Applications for Medical Device Product Code "MYB"
(Pillow,Cervical(For Mild Sleep Apnea))

FDA 510(k) Number Applicant Device Name Decision Date
K140190 ADVANCED BRAIN MONITORING, INC. NIGHT SHIFT 05/29/2014
K023010 AEOLUS INTERNATIONAL CORPORATION SNIFF POSITION PILLOWS/POPITZ PILLOWS 10/01/2002
K990871 LIFESLEEP SYSTEMS, INC. PILLOWPOSITIVE CERVICAL PILLOW 06/10/1999
K180608 NightBalance BV Lunoa System 06/05/2018
K040161 SLEEP DEVICES, INC. SONA PILLOW 04/30/2004
K100160 SLEEP SPECIALISTS, LLC ZZOMA POSITIONAL SLEEPER MODEL 001 05/11/2010


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