Product code MYB
- Device name
- Pillow, Cervical (For Mild Sleep Apnea)
- Medical specialty
- Dental
- Device class
- 2
- Regulation number
- 872.5570
- Review panel
- EN
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K180608 | Lunoa System | Nightbalance BV | 2018-06-05 |
| K140190 | NIGHT SHIFT | Advanced Brain Monitoring, Inc. | 2014-05-29 |
| K100160 | ZZOMA POSITIONAL SLEEPER MODEL 001 | Sleep Specialists, LLC | 2010-05-11 |
| K040161 | SONA PILLOW | Sleep Devices, Inc. | 2004-04-30 |
| K023010 | SNIFF POSITION PILLOWS/POPITZ PILLOWS | Aeolus International Corporation | 2002-10-01 |
| K990871 | PILLOWPOSITIVE CERVICAL PILLOW | Lifesleep Systems, Inc. | 1999-06-10 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00850063034319 | Night Shift | ADVANCED BRAIN MONITORING, INC. | 2025-12-08 |
| 00850063034296 | Night Shift | ADVANCED BRAIN MONITORING, INC. | 2025-12-08 |
| 70850015266194 | Night Shift | ADVANCED BRAIN MONITORING, INC. | 2025-10-27 |
| 00850063034289 | Night Shift | ADVANCED BRAIN MONITORING, INC. | 2025-07-21 |
| 00850063034272 | Night Shift | ADVANCED BRAIN MONITORING, INC. | 2025-07-21 |
| 00850015266515 | Night Shift | ADVANCED BRAIN MONITORING, INC. | 2022-03-29 |
| 00850015266508 | Night Shift | ADVANCED BRAIN MONITORING, INC. | 2022-03-29 |
| 00850015266492 | Night Shift | ADVANCED BRAIN MONITORING, INC. | 2022-03-29 |
| 00606959054615 | NightBalance | Respironics, Inc. | 2020-12-15 |
| 00850015266126 | Night Shift | ADVANCED BRAIN MONITORING, INC. | 2020-09-30 |
| 00850015266188 | Night Shift | ADVANCED BRAIN MONITORING, INC. | 2020-09-30 |
| 00850015266171 | Night Shift | ADVANCED BRAIN MONITORING, INC. | 2020-09-30 |
| 00850015266164 | Night Shift | ADVANCED BRAIN MONITORING, INC. | 2020-09-30 |
| 00850015266157 | Night Shift | ADVANCED BRAIN MONITORING, INC. | 2020-09-30 |
| 00850015266140 | Night Shift | ADVANCED BRAIN MONITORING, INC. | 2020-09-30 |
| 00850015266133 | Night Shift | ADVANCED BRAIN MONITORING, INC. | 2020-09-30 |
| 00850015266119 | Night Shift | ADVANCED BRAIN MONITORING, INC. | 2020-09-30 |
| 00850015266102 | Night Shift | ADVANCED BRAIN MONITORING, INC. | 2020-09-30 |
| 00850015266096 | Night Shift | ADVANCED BRAIN MONITORING, INC. | 2020-09-30 |
| 00850015266089 | Night Shift | ADVANCED BRAIN MONITORING, INC. | 2020-09-30 |
| 00850015266072 | Night Shift | ADVANCED BRAIN MONITORING, INC. | 2020-09-30 |
| 00606959059597 | NightBalance | Respironics, Inc. | 2020-09-23 |
| 00606959059580 | NightBalance | Respironics, Inc. | 2020-09-23 |
| 00606959057517 | NightBalance | Respironics, Inc. | 2020-09-23 |
| 00851113007994 | Night Shift | ADVANCED BRAIN MONITORING, INC. | 2019-11-21 |
| 20851113007035 | Night Shift | ADVANCED BRAIN MONITORING, INC. | 2019-04-30 |
| 10851113007939 | Night Shift | ADVANCED BRAIN MONITORING, INC. | 2019-01-10 |
| 08719689344504 | Lunoa | NightBalance Holding B.V. | 2018-08-20 |
| 08719689344511 | Lunoa | NightBalance Holding B.V. | 2018-08-20 |
| 10851113007038 | Night Shift | ADVANCED BRAIN MONITORING, INC. | 2016-09-23 |