NEU-ION HEMODIALYIS WATER TREATMENT SYSTEM— 510(k) K001811

Name: FDA 510(k) clearance K001811
Creator: U.S. Food and Drug Administration
Published: 2000-10-25

Substantially Equivalent

Neu-Ion, Inc.

FDA 510(k) clearance K001811 for NEU-ION HEMODIALYIS WATER TREATMENT SYSTEM, Substantially Equivalent on 2000-10-25. Applicant: Neu-Ion, Inc.. Device class: 2.

Clearance details

Applicant: Neu-Ion, Inc.
Product code: Code FIP
Device class: Class 2
Regulation: 21 CFR 876.5665
Advisory panel: Gastroenterology, Urology
Date received: 2000-06-15
Decision date: 2000-10-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Baltimore, MD, 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.