The following data is part of a premarket notification filed by Better Water, Inc. with the FDA for Water Purification System For Hemodialysis.
| Device ID | K920186 |
| 510k Number | K920186 |
| Device Name: | WATER PURIFICATION SYSTEM FOR HEMODIALYSIS |
| Classification | Subsystem, Water Purification |
| Applicant | BETTER WATER, INC. 607 SWAN DRIVE, STE.E Smyrna, TN 37167 |
| Contact | Bob Cline |
| Correspondent | Bob Cline BETTER WATER, INC. 607 SWAN DRIVE, STE.E 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 | 1992-01-14 |
| Decision Date | 1995-06-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| DD0001 | K920186 | 000 |