MATRIX DIGITAL REVERSE OSMOSIS WATER TREATMENT SYSTEM, MODEL EQRMD SERIES— 510(k) K051620

Substantially Equivalent

Better Water, Inc.

FDA 510(k) clearance K051620 for MATRIX DIGITAL REVERSE OSMOSIS WATER TREATMENT SYSTEM, MODEL EQRMD SERIES, Substantially Equivalent on 2005-11-18. Applicant: Better Water, Inc..

Clearance details

Applicant: Better Water, Inc.
Product code: Code FIP
Advisory panel: Gastroenterology, Urology
Date received: 2005-06-17
Decision date: 2005-11-18
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.