FDA 510(k)

AmeriWater MediQA Reverse Osmosis System (MSP3HF)

Номер K: K223656 · 2023-02-13

Дата решения2023-02-13

Код продуктаFIP

Консультативный комитетGU

РешениеSubstantially Equivalent

Описание устройства

AmeriWater MediQA Reverse Osmosis System (MSP3HF) is the device name listed in this FDA 510(k) record. The listed applicant is AmeriWater, LLC. It received FDA 510(k) clearance on 2023-02-13 under 510(k) number K223656. 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 AmeriWater MediQA Reverse Osmosis System (MSP3HF)?

AmeriWater MediQA Reverse Osmosis System (MSP3HF) is a medical device that received FDA 510(k) clearance on 2023-02-13. The listed applicant is AmeriWater, LLC. The 510(k) number is K223656.

When did AmeriWater MediQA Reverse Osmosis System (MSP3HF) receive FDA 510(k) clearance?

AmeriWater MediQA Reverse Osmosis System (MSP3HF) received FDA 510(k) clearance on 2023-02-13, under 510(k) number K223656.

Who is the listed applicant for AmeriWater MediQA Reverse Osmosis System (MSP3HF)?

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

What is the FDA product code for AmeriWater MediQA Reverse Osmosis System (MSP3HF)?

The FDA product code for AmeriWater MediQA Reverse Osmosis System (MSP3HF) 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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