The following data is part of a premarket notification filed by Ecolab Inc. with the FDA for Ecolab Pou Water Filter.
| Device ID | K173164 |
| 510k Number | K173164 |
| Device Name: | Ecolab POU Water Filter |
| Classification | System, Water Purification, General Medical Use |
| Applicant | Ecolab Inc. One Ecolab Place St. Paul, MN 55102 |
| Contact | Jennifer Willner |
| Correspondent | Jennifer Willner Ecolab Inc. One Ecolab Place St. Paul, MN 55102 |
| Product Code | NHV |
| CFR Regulation Number | 876.5665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-29 |
| Decision Date | 2018-06-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18425921000554 | K173164 | 000 |
| 18425921000530 | K173164 | 000 |
| 18425921000578 | K173164 | 000 |
| 18425921000592 | K173164 | 000 |
| 18425921000615 | K173164 | 000 |
| 18425921000639 | K173164 | 000 |
| 08425921000038 | K173164 | 000 |
| 18425921000059 | K173164 | 000 |
| 08425921000076 | K173164 | 000 |
| 18425921000097 | K173164 | 000 |
| 08425921000502 | K173164 | 000 |