510(k) K161844

Matrix Pre-Treatment Controller by Better Water, LLC — Product Code FIP

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