AMERIWATER ALARM PANEL - BASE MODEL AND REMOTE, BASE MODEL & REMOTE WITH CONDUCTIVITY, BASE MODEL & REMOTE WITH RESISTIV— 510(k) K121022

Substantially Equivalent

Ameriwater

FDA 510(k) clearance K121022 for AMERIWATER ALARM PANEL - BASE MODEL AND REMOTE, BASE MODEL & REMOTE WITH CONDUCTIVITY, BASE MODEL & REMOTE WITH RESISTIV, Substantially Equivalent on 2012-09-17. Applicant: Ameriwater.

Clearance details

Applicant: Ameriwater
Product code: Code FIP
Advisory panel: Gastroenterology, Urology
Date received: 2012-04-04
Decision date: 2012-09-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dayton, OH, 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.