510(k) K140190
K140190 is an FDA 510(k) premarket notification submitted by Advanced Brain Monitoring, Inc. for the device "NIGHT SHIFT". The FDA issued a decision of Substantially Equivalent on May 29, 2014. The device falls under product code MYB (Pillow, Cervical (For Mild Sleep Apnea)), a Class II device regulated under 21 CFR 872.5570. Advanced Brain Monitoring, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 29, 2014
- Date Received
- January 24, 2014
- 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