UPT Series Medical RO Water Treatment System— 510(k) K250514

Substantially Equivalent

Specialty Water Technologies, Inc.

FDA 510(k) clearance K250514 for UPT Series Medical RO Water Treatment System, Substantially Equivalent on 2025-03-17. Applicant: Specialty Water Technologies, Inc..

Clearance details

Applicant
Specialty Water Technologies, Inc.
Product code
Code FIP
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Portland, TN, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code FIP

product code FIP
Malfunction
490
Total
490

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.