510(k) K990871
- Device
- PILLOWPOSITIVE CERVICAL PILLOW
- Applicant
- LIFESLEEP SYSTEMS, INC.
- 510(k) number
- K990871
- Product code
- MYB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1999-06-10
- Date received
- 1999-03-16
- Regulation
- 872.5570
- Classification name
- Pillow, Cervical (for Mild Sleep Apnea)
- Medical specialty
- Dental
- Review panel
- Ear Nose & Throat
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- HOWARD M HOLSTEIN
- Address
- 555 Thirteenth St. NW Washington DC US 20004 20004
FDA Registration Numbers#
- 3000126629
- 3023194188
- 2518422
- 3008388260
- 3017965926
- 3023272766
- 3008812550
- 3004964738
- 3018783526
Source Documents#
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 |
| K023010 | SNIFF POSITION PILLOWS/POPITZ PILLOWS | Aeolus International Corporation | 2002-10-01 |
Legacy Summary#
summary
FDA Review#
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