510(k) K924695— ASEPTECH PORTABLE RO+ SYSTEM

Substantially Equivalent

Dayton Water Systems

Clearance details

Applicant: Dayton Water Systems
Product code: Code FIP
Advisory panel: Gastroenterology, Urology
Date received: 1992-09-17
Decision date: 1995-08-24
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.