Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Subsystem, Water Purification
510(k) Number K051620
Device Name MATRIX DIGITAL REVERSE OSMOSIS WATER TREATMENT SYSTEM, MODEL EQRMD SERIES
Applicant
Better Water, Inc.
698 Swan Dr.
Smyrna,  TN  37167
Applicant Contact MICHAEL CLINE
Correspondent
Better Water, Inc.
698 Swan Dr.
Smyrna,  TN  37167
Correspondent Contact MICHAEL CLINE
Regulation Number876.5665
Classification Product Code
FIP  
Date Received06/17/2005
Decision Date 11/18/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-