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FDA 510(k)

MATRIX DIGITAL REVERSE OSMOSIS WATER TREATMENT SYSTEM, MODEL EQRMD SERIES

K-Number: K051620 · 2005-11-18

ApplicantBetter Water, Inc.
Decision Date2005-11-18
Product CodeFIP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MATRIX DIGITAL REVERSE OSMOSIS WATER TREATMENT SYSTEM, MODEL EQRMD SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Better Water, Inc.. It received FDA 510(k) clearance on 2005-11-18 under 510(k) number K051620. 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 MATRIX DIGITAL REVERSE OSMOSIS WATER TREATMENT SYSTEM, MODEL EQRMD SERIES?

MATRIX DIGITAL REVERSE OSMOSIS WATER TREATMENT SYSTEM, MODEL EQRMD SERIES is a medical device that received FDA 510(k) clearance on 2005-11-18. The listed applicant is Better Water, Inc.. The 510(k) number is K051620.

When did MATRIX DIGITAL REVERSE OSMOSIS WATER TREATMENT SYSTEM, MODEL EQRMD SERIES receive FDA 510(k) clearance?

MATRIX DIGITAL REVERSE OSMOSIS WATER TREATMENT SYSTEM, MODEL EQRMD SERIES received FDA 510(k) clearance on 2005-11-18, under 510(k) number K051620.

Who is the listed applicant for MATRIX DIGITAL REVERSE OSMOSIS WATER TREATMENT SYSTEM, MODEL EQRMD SERIES?

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

What is the FDA product code for MATRIX DIGITAL REVERSE OSMOSIS WATER TREATMENT SYSTEM, MODEL EQRMD SERIES?

The FDA product code for MATRIX DIGITAL REVERSE OSMOSIS WATER TREATMENT SYSTEM, MODEL EQRMD SERIES is FIP.

Related Clinical Trials

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Other records listing Better Water, 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.

K992793SODIUM BICARBONATE MIXING/DELIVERY SYSTEM, AND THE CONCENTRATE DELIVERY SYSTEMK954928PORTABLE REVERSE OSMOSIS MACHINEK920186WATER PURIFICATION SYSTEM FOR HEMODIALYSIS

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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