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FDA 510(k)

AmeriWater MediQA Reverse Osmosis System (MSP3HF)

K-Number: K223656 · 2023-02-13

ApplicantAmeriWater, LLC
Decision Date2023-02-13
Product CodeFIP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AmeriWater MediQA Reverse Osmosis System (MSP3HF) is a medical device manufactured by AmeriWater, LLC. It received FDA 510(k) clearance on 2023-02-13 under approval number K223656. 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 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. It is manufactured by AmeriWater, LLC. The 510(k) number is K223656.

When was AmeriWater MediQA Reverse Osmosis System (MSP3HF) approved by the FDA?

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

What company makes AmeriWater MediQA Reverse Osmosis System (MSP3HF)?

AmeriWater MediQA Reverse Osmosis System (MSP3HF) is manufactured by AmeriWater, LLC.

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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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.

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