K042018

Substantially Equivalent

ACUTE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM, CENTRAL PEDI SYSTEM, BACK-UP PEDI SYSTEM

Applicant: Simply Clean Air & Water, Inc.
Product code: FIP
Advisory panel: Gastroenterology, Urology
Date received: 2004-07-27
Decision date: 2005-04-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newington, CT, US

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.