Ecolab POU Water Filter
FDA 510(k) K173164 · Ecolab, Inc.
510(k) numberK173164
Submission
- Device name
- Ecolab POU Water Filter
- Applicant
- Ecolab, Inc.
St. Paul, MN, US - Received
- September 29, 2017
- Decision date
- June 29, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NHV – System, Water Purification, General Medical Use
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5665
- Specialty
- Gastroenterology, Urology
The device is a portable water treatment system which features components and technology similar to water treatment systems previously cleared for hemodialysis. The difference lies with the intended use, as the proposed device is not intended for use in hemodialysis applications, for which a product code currently exists. Instead, the proposed device is intended for use to purify water for…
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| K152522 | ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming DrapesLHC · Special | 01/15/2016SE |
| K150190 | IntraTemp Solution WarmerLHC · Special | 02/26/2015SE |
| K142173 | Non-Sterile ORS-400N Scope Pillow Warmer DrapeLHC · Traditional | 12/30/2014SE |
| K142080 | Non-Sterile Ors Warning Drapes/Slush+Warmer Disc-Drape/Slush+Warmer Palte-Drape /Fluid…LHC · Special | 08/28/2014SE |
| K883593 | #400 Brook Airway & #900 Professional Brook AirwayCAE · Traditional | 09/30/1988SE |
Questions and answers
When was Ecolab POU Water Filter cleared by the FDA?
Ecolab POU Water Filter (K173164) received a 510(k) decision of Substantially Equivalent on June 29, 2018, 273 days after the submission was received.
What is the product code of K173164?
The FDA product code is NHV – System, Water Purification, General Medical Use, a Class II (moderate risk) device regulated under 21 CFR 876.5665.