The following data is part of a premarket notification filed by Better Water, Inc. with the FDA for Portable Reverse Osmosis Machine.
Device ID | K954928 |
510k Number | K954928 |
Device Name: | PORTABLE REVERSE OSMOSIS MACHINE |
Classification | Subsystem, Water Purification |
Applicant | BETTER WATER, INC. 698 SWAN DR. Smyrna, TN 37167 |
Contact | Mike Cline |
Correspondent | Mike Cline BETTER WATER, INC. 698 SWAN DR. Smyrna, TN 37167 |
Product Code | FIP |
CFR Regulation Number | 876.5665 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-10-26 |
Decision Date | 1996-01-24 |