ULTRAPURE WATER TREATMENT SYSTEM FOR HEMODIALYSIS— 510(k) K981680

Name: FDA 510(k) clearance K981680
Creator: U.S. Food and Drug Administration
Published: 1998-12-31

Substantially Equivalent

Dayton Water Systems

FDA 510(k) clearance K981680 for ULTRAPURE WATER TREATMENT SYSTEM FOR HEMODIALYSIS, Substantially Equivalent on 1998-12-31. Applicant: Dayton Water Systems. Device class: 2.

Clearance details

Applicant: Dayton Water Systems
Product code: Code FIP
Device class: Class 2
Regulation: 21 CFR 876.5665
Advisory panel: Gastroenterology, Urology
Date received: 1998-05-13
Decision date: 1998-12-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dayton, OH, 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.