INFRARED EAR THERMOMETER, MODELS TM819, TM820, TM817, TM810A, TM810B, TM818 AND TM818A— 510(k) K102935

Substantially Equivalent

Kingtech Enterprise, Ltd.

FDA 510(k) clearance K102935 for INFRARED EAR THERMOMETER, MODELS TM819, TM820, TM817, TM810A, TM810B, TM818 AND TM818A, Substantially Equivalent on 2011-05-27. Applicant: Kingtech Enterprise, Ltd..

Clearance details

Applicant: Kingtech Enterprise, Ltd.
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2010-10-04
Decision date: 2011-05-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dongguan, CN

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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.