ACUTE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM, CENTRAL PEDI SYSTEM, BACK-UP PEDI SYSTEM— 510(k) K071104

Substantially Equivalent

Flier'S Quality Water Systems, Inc.

FDA 510(k) clearance K071104 for ACUTE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM, CENTRAL PEDI SYSTEM, BACK-UP PEDI SYSTEM, Substantially Equivalent on 2008-01-14. Applicant: Flier'S Quality Water Systems, Inc..

Clearance details

Applicant: Flier'S Quality Water Systems, Inc.
Product code: Code FIP
Advisory panel: Gastroenterology, Urology
Date received: 2007-04-19
Decision date: 2008-01-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Byron Center, MI, 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.