
Cantel
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EON Portable Reverse Osmosis Water Purification System is an FDA 510(k)-cleared medical device (K171099) manufactured by Cantel. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 4, 2018. Regulation: 8.