510(k) K142285— AmeriWater Heatsan, 3-phase, 208v, 60hz, AmeriWater Heatsan, 3-phase, 460V, 60hz, Ameriwater Heatsan, 3-phase, 575v, 60hz

Substantially Equivalent

Ameriwater

Clearance details

Applicant: Ameriwater
Product code: Code FIP
Advisory panel: Gastroenterology, Urology
Date received: 2014-08-18
Decision date: 2014-12-01
Decision: Substantially Equivalent
Clearance type: Traditional
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.