K250514
- 510(k) number
- K250514
- Device name
- UPT Series Medical RO Water Treatment System
- Applicant
- Specialty Water Technologies, Inc. TN · US
- Product code
- FIP — Subsystem, Water Purification
- Decision date
- 2025-03-17
- Date received
- 2025-02-21
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K250514.pdf
Official FDA record: K250514
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.