Matrix Pre-Treatment Controller— 510(k) K161844

Substantially Equivalent

Better Water, LLC

FDA 510(k) clearance K161844 for Matrix Pre-Treatment Controller, Substantially Equivalent on 2016-12-13. Applicant: Better Water, LLC.

Clearance details

Applicant: Better Water, LLC
Product code: Code FIP
Advisory panel: Gastroenterology, Urology
Date received: 2016-07-05
Decision date: 2016-12-13
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Smyrna, TN, 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.