EON Portable RO Water Purification System— 510(k) K200670

Substantially Equivalent

Mar Cor Purification, Inc.

FDA 510(k) clearance K200670 for EON Portable RO Water Purification System, Substantially Equivalent on 2020-04-16. Applicant: Mar Cor Purification, Inc..

Clearance details

Applicant: Mar Cor Purification, Inc.
Product code: Code FIP
Advisory panel: Gastroenterology, Urology
Date received: 2020-03-13
Decision date: 2020-04-16
Decision: Substantially Equivalent
Clearance type: Special
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.