HEMODIALYSIS CARBON EXCHANGE, DUAL BED DEIONIZER EXCHANGE, MIXED BED DEIONIZER EXCHANGE, MODEL .60MAW,1.2MAW,3.6MAW, 1.2— 510(k) K092481

Name: FDA 510(k) clearance K092481
Creator: U.S. Food and Drug Administration
Published: 2010-04-02

Substantially Equivalent

New Aqua, LLC (Dba Aqua Systems)

FDA 510(k) clearance K092481 for HEMODIALYSIS CARBON EXCHANGE, DUAL BED DEIONIZER EXCHANGE, MIXED BED DEIONIZER EXCHANGE, MODEL .60MAW,1.2MAW,3.6MAW, 1.2, Substantially Equivalent on 2010-04-02. Applicant: New Aqua, LLC (Dba Aqua Systems). Device class: 2.

Clearance details

Applicant: New Aqua, LLC (Dba Aqua Systems)
Product code: Code FIP
Device class: Class 2
Regulation: 21 CFR 876.5665
Advisory panel: Gastroenterology, Urology
Date received: 2009-08-13
Decision date: 2010-04-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Avon, IN, 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.