510(k) K023010
- Device
- SNIFF POSITION PILLOWS/POPITZ PILLOWS
- Applicant
- AEOLUS INTERNATIONAL CORPORATION
- 510(k) number
- K023010
- Product code
- MYB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-10-01
- Date received
- 2002-09-09
- Regulation
- 872.5570
- Classification name
- Pillow, Cervical (for Mild Sleep Apnea)
- Medical specialty
- Dental
- Review panel
- Ear Nose & Throat
- Device class
- 2
- Clearance type
- Abbreviated
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- MICHAEL D POPITZ
- Address
- 64 Indian Cove Rd. Marion MA US 02738 02738
FDA Registration Numbers#
- 3000126629
- 3023194188
- 2518422
- 3008388260
- 3017965926
- 3023272766
- 3008812550
- 3004964738
- 3018783526
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code MYB #
| 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 |
| K990871 | PILLOWPOSITIVE CERVICAL PILLOW | Lifesleep Systems, Inc. | 1999-06-10 |
Legacy Summary#
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FDA Review#
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