510(k) K151637
K151637 is an FDA 510(k) premarket notification submitted by Specialty Water Technologies for the device "UPT Series Medical RO Water System". The FDA issued a decision of Substantially Equivalent on September 23, 2015. The device falls under product code FIP (Subsystem, Water Purification), a Class II device regulated under 21 CFR 876.5665. Specialty Water Technologies has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 23, 2015
- Date Received
- June 17, 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