510(k) K223656

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

K223656 is an FDA 510(k) premarket notification submitted by AmeriWater, LLC for the device "AmeriWater MediQA Reverse Osmosis System (MSP3HF)". The FDA issued a decision of Substantially Equivalent on February 13, 2023. The device falls under product code FIP (Subsystem, Water Purification), a Class II device regulated under 21 CFR 876.5665. AmeriWater, LLC has at least 10 other 510(k) clearances on record.

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