K982518

Substantially Equivalent

AQUA PURATOR-BIOTHERM, WISAP MODEL # 1608

Applicant: Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh
Product code: HET
Advisory panel: Obstetrics/Gynecology
Date received: 1998-07-20
Decision date: 1999-01-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sauerlach, DE

Adverse events under product code HET

product code HET

Malfunction: 10,504
Total: 10,504

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.