FDA device listing

EON Portable RO Water Purification System

FDA device listing 1529068909 · Evoqua Water Technologies, LLC

Key facts

Proprietary names EON Portable RO Water Purification System
Owner/operator Evoqua Water Technologies, LLC
Owner/operator number 10057016
Premarket submissions K171099
Product codes FIP
Device names FIP - Subsystem, Water Purification
Device class Class II
Classification regulations (21 CFR) 876.5665
Review panels Gastroenterology & Urology
Registered establishments Evoqua Water Technologies LLC
Establishment registrations 3019131
FEI numbers 3006475063
Establishment operations Manufacturer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • None UDI devices (GUDID) under the same submission
  • 1–9 Device listings citing the same submission
  • Yes Premarket submission listed

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device listings

Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.

Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database

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