The following data is part of a premarket notification filed by Better Water, Inc. with the FDA for Sodium Bicarbonate Mixing/delivery System, And The Concentrate Delivery System.
| Device ID | K992793 |
| 510k Number | K992793 |
| Device Name: | SODIUM BICARBONATE MIXING/DELIVERY SYSTEM, AND THE CONCENTRATE DELIVERY SYSTEM |
| Classification | Tank, Holding, Dialysis |
| Applicant | BETTER WATER, INC. 698 SWAN DR. Smyrna, TN 37167 |
| Contact | Mike S Sterling |
| Correspondent | Mike S Sterling BETTER WATER, INC. 698 SWAN DR. Smyrna, TN 37167 |
| Product Code | FIN |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-19 |
| Decision Date | 1999-11-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| BC0302 | K992793 | 000 |
| BC0002 | K992793 | 000 |
| BC0011 | K992793 | 000 |
| BC0012 | K992793 | 000 |
| BC0101 | K992793 | 000 |
| BC0111 | K992793 | 000 |
| BC0201 | K992793 | 000 |
| BC0202 | K992793 | 000 |
| BC0211 | K992793 | 000 |
| BC0301 | K992793 | 000 |
| BC0001 | K992793 | 000 |