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FDA 510(k)

MILLENIUM HX PORTABLE REVERSE OSMOSIS WATER PURIFICATION SYSTEM

K-Number: K110578 · 2011-05-20

ApplicantMar Cor Purification, Inc.
Decision Date2011-05-20
Product CodeFIP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MILLENIUM HX PORTABLE REVERSE OSMOSIS WATER PURIFICATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Mar Cor Purification, Inc.. It received FDA 510(k) clearance on 2011-05-20 under 510(k) number K110578. 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 PORTABLE REVERSE OSMOSIS WATER PURIFICATION SYSTEM?

MILLENIUM HX PORTABLE REVERSE OSMOSIS WATER PURIFICATION SYSTEM is a medical device that received FDA 510(k) clearance on 2011-05-20. The listed applicant is Mar Cor Purification, Inc.. The 510(k) number is K110578.

When did MILLENIUM HX PORTABLE REVERSE OSMOSIS WATER PURIFICATION SYSTEM receive FDA 510(k) clearance?

MILLENIUM HX PORTABLE REVERSE OSMOSIS WATER PURIFICATION SYSTEM received FDA 510(k) clearance on 2011-05-20, under 510(k) number K110578.

Who is the listed applicant for MILLENIUM HX PORTABLE REVERSE OSMOSIS WATER PURIFICATION SYSTEM?

The FDA 510(k) record lists Mar Cor Purification, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MILLENIUM HX PORTABLE REVERSE OSMOSIS WATER PURIFICATION SYSTEM?

The FDA product code for MILLENIUM HX PORTABLE REVERSE OSMOSIS WATER PURIFICATION SYSTEM is FIP.

Related Clinical Trials

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.

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Other records listing Mar Cor Purification, Inc. as applicant

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.

K200670EON Portable RO Water Purification SystemK192398Millenium HX

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

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

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