510(k) K161844
K161844 is an FDA 510(k) premarket notification submitted by Better Water, LLC for the device "Matrix Pre-Treatment Controller". The FDA issued a decision of Substantially Equivalent on December 13, 2016. The device falls under product code FIP (Subsystem, Water Purification), a Class II device regulated under 21 CFR 876.5665. Better Water, LLC has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 13, 2016
- Date Received
- July 5, 2016
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Subsystem, Water Purification
- Device Class
- Class II
- Regulation Number
- 876.5665
- Review Panel
- GU
- Submission Type