MILLENIUM HX PORTABLE REVERSE OSMOSIS WATER PURIFICATION SYSTEM— 510(k) K110578
Substantially EquivalentMar 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.. Device class: 2.
Clearance details
- Applicant
- Mar Cor Purification, Inc.
- Product code
- Code FIP
- Device class
- Class 2
- Regulation
- 21 CFR 876.5665
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Minneapolis, MN, US
Recent devices under product code FIP
view allMore clearances from Mar Cor Purification, Inc.
view allAdverse 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 →
Recalls naming K110578
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K110578.
Data sourced from openFDA. This site is unofficial and independent of the FDA.