The following data is part of a premarket notification filed by Better Water, Inc. with the FDA for Matrix Digital Reverse Osmosis Water Treatment System, Model Eqrmd Series.
Device ID | K051620 |
510k Number | K051620 |
Device Name: | MATRIX DIGITAL REVERSE OSMOSIS WATER TREATMENT SYSTEM, MODEL EQRMD SERIES |
Classification | Subsystem, Water Purification |
Applicant | BETTER WATER, INC. 698 SWAN DR. Smyrna, TN 37167 |
Contact | Michael Cline |
Correspondent | Michael Cline BETTER WATER, INC. 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 | 2005-06-17 |
Decision Date | 2005-11-18 |
Summary: | summary |