510(k) K223656
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