Ecolab POU Water Filter Spray Outlet, Ecolab POU Water Filter Nozzle Outlet, Ecolab POU Water Filter Shower Wand
FDA 510(k) clearance K182164 · decided 2019-03-29
Clearance details
- K-number
- K182164
- Device name
- Ecolab POU Water Filter Spray Outlet, Ecolab POU Water Filter Nozzle Outlet, Ecolab POU Water Filter Shower Wand
- Applicant
- Ecolab, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2018-08-10
- Decision date
- 2019-03-29
- Days to decision
- 231 days
- Clearance type
- Special
- Product code
- NHV
- Device class
- 2
- Regulation number
- 876.5665
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- St. Paul, MN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| i3 ONE (203100-S);i3 TWO connect (203200-S);i3 TWO direct (203300-S) (K222727) | I3 Membrane GmbH | 2023-06-02 |
| FILTRAY 2G Disposable Water Filters (K191563) | Aqua-Tools | 2019-10-25 |
| Ecolab POU Water Filter (K173164) | Ecolab, Inc. | 2018-06-29 |
| Pall QPoint Water Filter Capsule (Shower), Pall QPoint Water Filter Capsule (Faucet) (K163609) | Pall International Sarl | 2017-06-01 |
| HydraGuard 10 UltraFilter (K161467) | Nephros, Inc. | 2016-12-22 |
| NOSOGARD FILTERS (K153784) | Evoqua Water Technologies, LLC | 2016-10-21 |
| Pall-Aquasafe Water Filter (K153434) | Pall International Sarl | 2016-06-10 |
| Nephros S100 (K153084) | Nephros, Inc. | 2016-04-08 |
| NEPHROS DSU-H, NEPHROS SSU-H (K141731) | Nephros, Inc. | 2014-10-24 |
| MAINSTREAM WATER PURIFICATION DEVICE (K012716) | Prismedical Corp. | 2002-05-07 |
Recalls involving this device
No recalls on record reference this clearance.