FDA 510(k)

Matrix Pre-Treatment Controller

Номер K: K161844 · 2016-12-13

Дата решения2016-12-13

Код продуктаFIP

Консультативный комитетGU

РешениеSubstantially Equivalent

Описание устройства

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.

Часто задаваемые вопросы

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.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: FIP)

K250471AquaC UNO HFresenius Medical Care Renal Therapies Group, LLC K251851DIASAFEplusUS (F00013010)Fresenius Medical Care Renal Therapies Group, LLC K252181AquaAFresenius Medical Care North America K250514UPT Series Medical RO Water Treatment SystemSpecialty Water Technologies, Inc.K232953AquaBplus; AquaB LITEFresenius Medical Care Renal Therapies Group, LLC K223479AQUAbase nXB.Braun Medical, Inc.

Официальный источник

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