SUBMERSIBLE REVERSE OSMOSIS WATER PURIFICATION SYS— 510(k) K894300

Substantially Equivalent

U.S. Filter/Continental Water Systems

FDA 510(k) clearance K894300 for SUBMERSIBLE REVERSE OSMOSIS WATER PURIFICATION SYS, Substantially Equivalent on 1990-03-13. Applicant: U.S. Filter/Continental Water Systems.

Clearance details

Applicant
U.S. Filter/Continental Water Systems
Product code
Code FIP
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
San Antonio, TX, 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.