MILLENIUM HX PORTABLE REVERSE OSMOSIS WATER PURIFICATION SYSTEM— 510(k) K110578

Substantially Equivalent

Mar Cor Purification, Inc.

FDA 510(k) clearance K110578 for MILLENIUM HX PORTABLE REVERSE OSMOSIS WATER PURIFICATION SYSTEM, Substantially Equivalent on 2011-05-20. Applicant: Mar Cor Purification, Inc..

Clearance details

Applicant: Mar Cor Purification, Inc.
Product code: Code FIP
Advisory panel: Gastroenterology, Urology
Date received: 2011-03-01
Decision date: 2011-05-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FIP

product code FIP

Malfunction: 490
Total: 490

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.