510(k) K223656— AmeriWater MediQA Reverse Osmosis System (MSP3HF)

Substantially Equivalent

AmeriWater, LLC

Clearance details

Applicant: AmeriWater, LLC
Product code: Code FIP
Advisory panel: Gastroenterology, Urology
Date received: 2022-12-06
Decision date: 2023-02-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Dayton, OH, 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.