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FDA 510(k)

Millenium HX

K-Number: K192398 · 2019-10-03

ApplicantMar Cor Purification, Inc.
Decision Date2019-10-03
Product CodeFIP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Millenium HX is a medical device manufactured by Mar Cor Purification, Inc.. It received FDA 510(k) clearance on 2019-10-03 under approval number K192398. 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 Millenium HX?

Millenium HX is a medical device that received FDA 510(k) clearance on 2019-10-03. It is manufactured by Mar Cor Purification, Inc.. The 510(k) number is K192398.

When was Millenium HX approved by the FDA?

Millenium HX received FDA 510(k) clearance on 2019-10-03, under approval number K192398.

What company makes Millenium HX?

Millenium HX is manufactured by Mar Cor Purification, Inc..

What is the FDA product code for Millenium HX?

The FDA product code for Millenium HX is FIP.

Other Devices by Mar Cor Purification, Inc.

K200670EON Portable RO Water Purification System

Related Devices (Code: FIP)

K161844Matrix Pre-Treatment ControllerBetter Water, LLC K153329MED-TECH Water Systems Inc Exchangeable Carbon Tanks for DialysisMed-Tech Water Systems, Inc. K161304EndoPur FilterNephros, Inc. K171099EON Portable Reverse Osmosis Water Purification SystemCantel K182367DIASAFEplusUSFresenius Medical Care Renal Therapies Group, LLC K200670EON Portable RO Water Purification SystemMar Cor Purification, 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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