AquaC UNO H— 510(k) K143617

Substantially Equivalent

Vivonic GmbH

FDA 510(k) clearance K143617 for AquaC UNO H, Substantially Equivalent on 2015-10-19. Applicant: Vivonic GmbH.

Clearance details

Applicant: Vivonic GmbH
Product code: Code FIP
Advisory panel: Gastroenterology, Urology
Date received: 2014-12-19
Decision date: 2015-10-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sailauf, DE

Download summary PDF View on FDA.gov ↗

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.