FDA 510(k), K173164, Ecolab POU Water Filter

FDA 510(k), K173164, Ecolab POU Water Filter

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510(K) Number: K173164
Device Name: Ecolab POU Water Filter
Manufacturer: Ecolab Inc.
Device Classification Name: system, water purification, general medical use
Regulation Number: 876.5665
Classification Product Code: NHV
Date Received: 09/29/2017
Decision Date: 06/29/2018
Regulation Medical Specialty: Gastroenterology/Urology
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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