BIOPURE HX2 REVERSE OSMOSIS WATER PURIFICATION SYSTEM— 510(k) K133149

Name: FDA 510(k) clearance K133149
Creator: U.S. Food and Drug Administration
Published: 2014-04-30

Substantially Equivalent

Mar Cor Purification, Inc.

FDA 510(k) clearance K133149 for BIOPURE HX2 REVERSE OSMOSIS WATER PURIFICATION SYSTEM, Substantially Equivalent on 2014-04-30. 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: 2013-10-17
Decision date: 2014-04-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

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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.