510(k) K193239
K193239 is an FDA 510(k) premarket notification submitted by Mpowrx Health And Wellness Products 2012, Inc. for the device "MPowRx Snoring Solution (also known as Good Morning Snore Solution)". The FDA issued a decision of Substantially Equivalent on Jan 3, 2020. The device falls under product code LRK (Device, Anti-Snoring), a Class II device regulated under 21 CFR 872.5570.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 3, 2020
- Date Received
- Nov 25, 2019
- Clearance Type
- Traditional
- 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
- 510(k)