510(k) K213507
K213507 is an FDA 510(k) premarket notification submitted by Fresenius Medical Care Rental Therapies Group, LLC for the device "AquaA". The FDA issued a decision of Substantially Equivalent on July 27, 2022. The device falls under product code FIP (Subsystem, Water Purification), a Class II device regulated under 21 CFR 876.5665.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 27, 2022
- Date Received
- November 1, 2021
- Clearance Type
- Traditional
- 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