SNIFF POSITION PILLOWS/POPITZ PILLOWS
FDA 510(k) clearance K023010 · decided 2002-10-01
Clearance details
- K-number
- K023010
- Device name
- SNIFF POSITION PILLOWS/POPITZ PILLOWS
- Applicant
- Aeolus International Corporation
- Decision
- Substantially Equivalent
- Date received
- 2002-09-09
- Decision date
- 2002-10-01
- Days to decision
- 22 days
- Clearance type
- Abbreviated
- Product code
- MYB
- Device class
- 2
- Regulation number
- 872.5570
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Marion, MA, 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 |
| NIGHT SHIFT (K140190) | Advanced Brain Monitoring, Inc. | 2014-05-29 |
| ZZOMA POSITIONAL SLEEPER MODEL 001 (K100160) | Sleep Specialists, LLC | 2010-05-11 |
| SONA PILLOW (K040161) | Sleep Devices, Inc. | 2004-04-30 |
| PILLOWPOSITIVE CERVICAL PILLOW (K990871) | Lifesleep Systems, Inc. | 1999-06-10 |
Recalls involving this device
No recalls on record reference this clearance.