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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 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.

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. 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.

Related Devices (Code: FIP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250471AquaC UNO HFresenius Medical Care Renal Therapies Group, LLCK251851DIASAFEplusUS (F00013010)Fresenius Medical Care Renal Therapies Group, LLCK252181AquaAFresenius Medical Care North AmericaK250514UPT Series Medical RO Water Treatment SystemSpecialty Water Technologies, Inc.K232953AquaBplus; AquaB LITEFresenius Medical Care Renal Therapies Group, LLCK223479AQUAbase nXB.Braun Medical, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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