510(k) K182164
- Device
- Ecolab POU Water Filter Spray Outlet, Ecolab POU Water Filter Nozzle Outlet, Ecolab POU Water Filter Shower Wand
- Applicant
- Ecolab Inc.
- 510(k) number
- K182164
- Product code
- NHV
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-03-29
- Date received
- 2018-08-10
- Regulation
- 876.5665
- Classification name
- System, Water Purification, General Medical Use
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Jennifer Willner
- Address
- 1 Ecolab Pl. St. Paul MN US 55102 55102
FDA Registration Numbers#
- 3030626361
- 3002807315
- 9615942
- 3005698329
- 3008412416
- 3019907057
- 3022699154
- 9680602
- 3003337893
- 3005562917
- 3010132111
- 3014640782
- 3012821221
- 3008102042
- 3005695808
Source Documents#
Other 510(k) Records For Product Code NHV #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K222727 | i3 ONE (203100-S);i3 TWO connect (203200-S);i3 TWO direct (203300-S) | I3 Membrane GmbH | 2023-06-02 |
| K191563 | FILTRAY 2G Disposable Water Filters | Aqua-Tools | 2019-10-25 |
| K173164 | Ecolab POU Water Filter | Ecolab, Inc. | 2018-06-29 |
| K163609 | Pall QPoint Water Filter Capsule (Shower), Pall QPoint Water Filter Capsule (Faucet) | Pall International Sarl | 2017-06-01 |
| K161467 | HydraGuard 10 UltraFilter | Nephros, Inc. | 2016-12-22 |
| K153784 | NOSOGARD FILTERS | Evoqua Water Technologies, LLC | 2016-10-21 |
| K153434 | Pall-Aquasafe Water Filter | Pall International Sarl | 2016-06-10 |
| K153084 | Nephros S100 | Nephros, Inc. | 2016-04-08 |
| K141731 | NEPHROS DSU-H, NEPHROS SSU-H | Nephros, Inc. | 2014-10-24 |
| K012716 | MAINSTREAM WATER PURIFICATION DEVICE | Prismedical Corp. | 2002-05-07 |