HI-FLO THERME PNEU 45, WISAP #7083, 7083V— 510(k) K031014

Substantially Equivalent

Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh

FDA 510(k) clearance K031014 for HI-FLO THERME PNEU 45, WISAP #7083, 7083V, Substantially Equivalent on 2003-06-27. Applicant: Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh.

Clearance details

Applicant: Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh
Product code: Code HIF
Advisory panel: Obstetrics/Gynecology
Date received: 2003-03-31
Decision date: 2003-06-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sauerlach, DE

Download summary PDF View on FDA.gov ↗

Adverse events under product code HIF

product code HIF

Death: 19
Injury: 578
Malfunction: 5,639
Total: 6,236

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.