K092481

Substantially Equivalent

HEMODIALYSIS CARBON EXCHANGE, DUAL BED DEIONIZER EXCHANGE, MIXED BED DEIONIZER EXCHANGE, MODEL .60MAW,1.2MAW,3.6MAW, 1.2

Applicant: New Aqua, LLC (Dba Aqua Systems)
Product code: FIP
Advisory panel: Gastroenterology, Urology
Date received: 2009-08-13
Decision date: 2010-04-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Avon, IN, 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.