510(k) K153329
K153329 is an FDA 510(k) premarket notification submitted by Med-Tech Water Systems, Inc. for the device "MED-TECH Water Systems Inc Exchangeable Carbon Tanks for Dialysis". The FDA issued a decision of Substantially Equivalent on August 4, 2016. 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
- August 4, 2016
- Date Received
- November 19, 2015
- 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