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FDA 510(k)

EON Portable Reverse Osmosis Water Purification System

K-Number: K171099 · 2018-01-05

ApplicantCantel
Decision Date2018-01-05
Product CodeFIP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

EON Portable Reverse Osmosis Water Purification System is the device name listed in this FDA 510(k) record. The listed applicant is Cantel. It received FDA 510(k) clearance on 2018-01-05 under 510(k) number K171099. The device is classified under product code FIP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EON Portable Reverse Osmosis Water Purification System?

EON Portable Reverse Osmosis Water Purification System is a medical device that received FDA 510(k) clearance on 2018-01-05. The listed applicant is Cantel. The 510(k) number is K171099.

When did EON Portable Reverse Osmosis Water Purification System receive FDA 510(k) clearance?

EON Portable Reverse Osmosis Water Purification System received FDA 510(k) clearance on 2018-01-05, under 510(k) number K171099.

Who is the listed applicant for EON Portable Reverse Osmosis Water Purification System?

The FDA 510(k) record lists Cantel as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EON Portable Reverse Osmosis Water Purification System?

The FDA product code for EON Portable Reverse Osmosis Water Purification System is FIP.

Related Devices (Code: FIP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250471AquaC UNO HFresenius Medical Care Renal Therapies Group, LLCK251851DIASAFEplusUS (F00013010)Fresenius Medical Care Renal Therapies Group, LLCK252181AquaAFresenius Medical Care North AmericaK250514UPT Series Medical RO Water Treatment SystemSpecialty Water Technologies, Inc.K232953AquaBplus; AquaB LITEFresenius Medical Care Renal Therapies Group, LLCK223479AQUAbase nXB.Braun Medical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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