The following data is part of a premarket notification filed by Better Water, Llc. with the FDA for Matrix Pre-treatment Controller.
Device ID | K161844 |
510k Number | K161844 |
Device Name: | Matrix Pre-Treatment Controller |
Classification | Subsystem, Water Purification |
Applicant | BETTER WATER, LLC. 698 SWAN DR. Smyrna, TN 37167 |
Contact | Mike Cline |
Correspondent | Mike Cline BETTER WATER, LLC. 698 SWAN DR. Smyrna, TN 37167 |
Product Code | FIP |
CFR Regulation Number | 876.5665 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-07-05 |
Decision Date | 2016-12-13 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
PR0014 | K161844 | 000 |
PR0013 | K161844 | 000 |
PR0012 | K161844 | 000 |
PR0011 | K161844 | 000 |