FLOW-THERME, WISAP #7642— 510(k) K952508

Substantially Equivalent

Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh

FDA 510(k) clearance K952508 for FLOW-THERME, WISAP #7642, Substantially Equivalent on 1995-08-25. Applicant: Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh.

Clearance details

Applicant: Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh
Product code: Code HET
Advisory panel: Obstetrics/Gynecology
Date received: 1995-05-31
Decision date: 1995-08-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sauerlach, DE

Download summary PDF View on FDA.gov ↗

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.