INFRARED EAR THEROMETER— 510(k) K111703

Substantially Equivalent

Fudakang Industrial Co., Ltd.

FDA 510(k) clearance K111703 for INFRARED EAR THEROMETER, Substantially Equivalent on 2012-03-29. Applicant: Fudakang Industrial Co., Ltd..

Clearance details

Applicant: Fudakang Industrial Co., Ltd.
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2011-06-17
Decision date: 2012-03-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Buena Park, CA, US

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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.