FDA 510(k)

EON Portable Reverse Osmosis Water Purification System

Номер K: K171099 · 2018-01-05

ЗаявительCantel

Дата решения2018-01-05

Код продуктаFIP

Консультативный комитетGU

РешениеSubstantially Equivalent

Описание устройства

EON Portable Reverse Osmosis Water Purification System is the device name listed in this FDA 510(k) record. The listed applicant is Cantel. It received FDA 510(k) clearance on 2018-01-05 under 510(k) number K171099. 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 EON Portable Reverse Osmosis Water Purification System?

EON Portable Reverse Osmosis Water Purification System is a medical device that received FDA 510(k) clearance on 2018-01-05. The listed applicant is Cantel. The 510(k) number is K171099.

When did EON Portable Reverse Osmosis Water Purification System receive FDA 510(k) clearance?

EON Portable Reverse Osmosis Water Purification System received FDA 510(k) clearance on 2018-01-05, under 510(k) number K171099.

Who is the listed applicant for EON Portable Reverse Osmosis Water Purification System?

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

What is the FDA product code for EON Portable Reverse Osmosis Water Purification System?

The FDA product code for EON Portable Reverse Osmosis Water Purification System 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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