MYB · Class II · 21 CFR 872.5570

FDA Product Code MYB: Pillow, Cervical (for Mild Sleep Apnea)

Leading manufacturers include Lifesleep Systems, Inc., Aeolus International Corporation and Sleep Devices, Inc..

6
Total
6
Cleared
89d
Avg days
1999
Since

FDA 510(k) Cleared Pillow, Cervical (for Mild Sleep Apnea) Devices (Product Code MYB)

6 devices
1–6 of 6
Cleared Jun 05, 2018
Lunoa System
K180608
Nightbalance BV
Ear, Nose, Throat · 90d
Cleared May 29, 2014
NIGHT SHIFT
K140190
Advanced Brain Monitoring, Inc.
Ear, Nose, Throat · 125d
Cleared May 11, 2010
ZZOMA POSITIONAL SLEEPER MODEL 001
K100160
Sleep Specialists, LLC
Ear, Nose, Throat · 111d
Cleared Apr 30, 2004
SONA PILLOW
K040161
Sleep Devices, Inc.
Ear, Nose, Throat · 98d
Cleared Oct 01, 2002
SNIFF POSITION PILLOWS/POPITZ PILLOWS
K023010
Aeolus International Corporation
Ear, Nose, Throat · 22d
Cleared Jun 10, 1999
PILLOWPOSITIVE CERVICAL PILLOW
K990871
Lifesleep Systems, Inc.
Ear, Nose, Throat · 86d

About Product Code MYB - Regulatory Context