DAYTON WATER SYSTEMS ULTRAPURE WATER TREATMENT SYSTEMS FOR HEMODIALYSIS— 510(k) K021352

Substantially Equivalent

Dayton Water Systems

FDA 510(k) clearance K021352 for DAYTON WATER SYSTEMS ULTRAPURE WATER TREATMENT SYSTEMS FOR HEMODIALYSIS, Substantially Equivalent on 2002-08-01. Applicant: Dayton Water Systems.

Clearance details

Applicant: Dayton Water Systems
Product code: Code FIP
Advisory panel: Gastroenterology, Urology
Date received: 2002-04-29
Decision date: 2002-08-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Dayton, OH, US

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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.