FDA 510(k)

Sistema de Osmose Inversa MediQA AmeriWater (MSP3HF)

Número K: K223656 · 2023-02-13

Data da decisão2023-02-13

Código do produtoFIP

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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