510(k) K990871
K990871 is an FDA 510(k) premarket notification submitted by Lifesleep Systems, Inc. for the device "PILLOWPOSITIVE CERVICAL PILLOW". The FDA issued a decision of Substantially Equivalent on June 10, 1999. 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
- June 10, 1999
- Date Received
- March 16, 1999
- 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