510(k) K040161
K040161 is an FDA 510(k) premarket notification submitted by Sleep Devices, Inc. for the device "SONA PILLOW". The FDA issued a decision of Substantially Equivalent on April 30, 2004. 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
- April 30, 2004
- Date Received
- January 23, 2004
- 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