510(k) K190051
K190051 is an FDA 510(k) premarket notification submitted by Zephyr Sleep Technologies, Inc. for the device "TD Clip". The FDA issued a decision of Substantially Equivalent on June 7, 2019. The device falls under product code LRK (Device, Anti-Snoring), a Class II device regulated under 21 CFR 872.5570. Zephyr Sleep Technologies, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 7, 2019
- Date Received
- January 11, 2019
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Anti-Snoring
- Device Class
- Class II
- Regulation Number
- 872.5570
- Review Panel
- DE
- Submission Type