K151946

Substantially Equivalent

Thermofit

Applicant: Orfit Industries
Product code: IYE
Advisory panel: Radiology
Date received: 2015-07-14
Decision date: 2015-11-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wijnegem, Belgium, BE

Adverse events under product code IYE

product code IYE

Malfunction: 455
Other: 3
Total: 458

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.