AQUABPLUS,AQUABPLUS & AQUABPLUS B2,AQUABPLUS&AQUABPLUS HF,AQUABPLUS& AQUABPLUS B2& AQUABLUS HF— 510(k) K133829

Substantially Equivalent

Vivonic GmbH

FDA 510(k) clearance K133829 for AQUABPLUS,AQUABPLUS & AQUABPLUS B2,AQUABPLUS&AQUABPLUS HF,AQUABPLUS& AQUABPLUS B2& AQUABLUS HF, Substantially Equivalent on 2014-04-22. Applicant: Vivonic GmbH.

Clearance details

Applicant: Vivonic GmbH
Product code: Code FIP
Advisory panel: Gastroenterology, Urology
Date received: 2013-12-17
Decision date: 2014-04-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sailauf, DE

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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.