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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| PB0003 | K954928 | 000 |
| PB0002 | K954928 | 000 |