AMERIWATER MRO PORTABLE REVERSE OSMOSIS SYSTEM - SINGLE PATIENT, 1 TO 3 STATION— 510(k) K111740

Substantially Equivalent

Ameriwater

FDA 510(k) clearance K111740 for AMERIWATER MRO PORTABLE REVERSE OSMOSIS SYSTEM - SINGLE PATIENT, 1 TO 3 STATION, Substantially Equivalent on 2011-10-05. Applicant: Ameriwater.

Clearance details

Applicant: Ameriwater
Product code: Code FIP
Advisory panel: Gastroenterology, Urology
Date received: 2011-06-21
Decision date: 2011-10-05
Decision: Substantially Equivalent
Clearance type: Abbreviated
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.