Dialysis System Upgrade: FDA 510-K System in Massachusetts

Problem: A New England-based dialysis clinic procured AmeriWater equipment for several key components of their dialysis water system. The clinic wanted to upgrade to a complete AmeriWater FDA 510-K dialysis system.

Solution: Pure Flow worked with the customer to swap AmeriWater equipment for legacy equipment. Upgrades to the following components were addressed:

  • AmeriWater MROX Reverse Osmosis system for legacy RO equipment
  • New softener system from AmeriWater
  • New RO pre-filter header and system from AmeriWater
  • Replacement of existing control panel with new AmeriWater control panel

Following the equipment installation, Pure Flow worked with AmeriWater to issue a new system 510-K certification, helping the clinic achieve their water system certification goals.