Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Matrix Pre-Treatment Controller

K-Number: K161844 · 2016-12-13

ApplicantBetter Water, LLC
Decision Date2016-12-13
Product CodeFIP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Matrix Pre-Treatment Controller is the device name listed in this FDA 510(k) record. The listed applicant is Better Water, LLC. It received FDA 510(k) clearance on 2016-12-13 under 510(k) number K161844. 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 Pre-Treatment Controller?

Matrix Pre-Treatment Controller is a medical device that received FDA 510(k) clearance on 2016-12-13. The listed applicant is Better Water, LLC. The 510(k) number is K161844.

When did Matrix Pre-Treatment Controller receive FDA 510(k) clearance?

Matrix Pre-Treatment Controller received FDA 510(k) clearance on 2016-12-13, under 510(k) number K161844.

Who is the listed applicant for Matrix Pre-Treatment Controller?

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

What is the FDA product code for Matrix Pre-Treatment Controller?

The FDA product code for Matrix Pre-Treatment Controller 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.

↑