510(k) K100160
K100160 is an FDA 510(k) premarket notification submitted by Sleep Specialists, LLC for the device "ZZOMA POSITIONAL SLEEPER MODEL 001". The FDA issued a decision of Substantially Equivalent on May 11, 2010. The device falls under product code MYB (Pillow, Cervical (For Mild Sleep Apnea)), a Class II device regulated under 21 CFR 872.5570.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 11, 2010
- Date Received
- January 20, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pillow, Cervical (For Mild Sleep Apnea)
- Device Class
- Class II
- Regulation Number
- 872.5570
- Review Panel
- EN
- Submission Type