510(k) K201600— Infrared thermometer, models KFT-22M, KFT-22, KFT-23, KFT-24, KFT-25, KFT-26, KFT-27, KFT-28

Substantially Equivalent

Kangfu Medical Equipment Factory

Clearance details

Applicant: Kangfu Medical Equipment Factory
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2020-06-12
Decision date: 2021-12-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wenzhou, CN

Adverse events under product code FLL

product code FLL

Death: 3
Malfunction: 557
Total: 560

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.