NIGHT SHIFT
FDA 510(k) clearance K140190 · decided 2014-05-29
Clearance details
- K-number
- K140190
- Device name
- NIGHT SHIFT
- Applicant
- Advanced Brain Monitoring, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-01-24
- Decision date
- 2014-05-29
- Days to decision
- 125 days
- Clearance type
- Traditional
- Product code
- MYB
- Device class
- 2
- Regulation number
- 872.5570
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Dousman, WI, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Lunoa System (K180608) | Nightbalance BV | 2018-06-05 |
| ZZOMA POSITIONAL SLEEPER MODEL 001 (K100160) | Sleep Specialists, LLC | 2010-05-11 |
| SONA PILLOW (K040161) | Sleep Devices, Inc. | 2004-04-30 |
| SNIFF POSITION PILLOWS/POPITZ PILLOWS (K023010) | Aeolus International Corporation | 2002-10-01 |
| PILLOWPOSITIVE CERVICAL PILLOW (K990871) | Lifesleep Systems, Inc. | 1999-06-10 |
Recalls involving this device
No recalls on record reference this clearance.