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510(k) K223656

AmeriWater MediQA Reverse Osmosis System (MSP3HF) by AmeriWater, LLC — Product Code FIP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 13, 2023
Date Received
December 6, 2022
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Subsystem, Water Purification
Device Class
Class II
Regulation Number
876.5665
Review Panel
GU
Submission Type

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  • K021560 — MODIFICATION TO AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS (August 14, 2003)
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