Pillow, Cervical (for Mild Sleep Apnea)
Dental · 21 CFR 872.5570
Recent MDR events
3 adverse event reports on file
Event type breakdown
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
9 firms currently registered for this product code
Tpi Custom Solutions
Ham Lake, MN, US
Advanced Brain Monitoring, Inc.
CARLSBAD, CA, US
Zhejiang E-cozy Electronic Technology Co., Ltd.
Wenzhou Zhejiang, CN
Ceva Logistics Limited
Daventry Northamptonshire, GB
Respironics Inc.
MURRYSVILLE, PA, US
Philips Electronics Ltd
Mississauga Ontario, CA
Sleep Specialists, Llc
Bala Cynwyd, PA, US
Ceva Logistics Netherlands Bv (venray)
Oostrum Limburgh, NL
Unitron Group Bv
IJzendijke Zeeland, NL
510(k) clearances
6 clearances for this product code
- Nightbalance BVJun 5, 2018
K180608 · Lunoa System
- Advanced Brain Monitoring, Inc.May 29, 2014
K140190 · NIGHT SHIFT
- Sleep Specialists, LLCMay 11, 2010
K100160 · ZZOMA POSITIONAL SLEEPER MODEL 001
- Sleep Devices, Inc.Apr 30, 2004
K040161 · SONA PILLOW
- Aeolus International CorporationOct 1, 2002
K023010 · SNIFF POSITION PILLOWS/POPITZ PILLOWS
- Lifesleep Systems, Inc.Jun 10, 1999
K990871 · PILLOWPOSITIVE CERVICAL PILLOW