INFRARED EAR THERMOMETER, MODEL ET-101A— 510(k) K082192

Substantially Equivalent

Sejoy Electronics & Instruments Co., Ltd.

FDA 510(k) clearance K082192 for INFRARED EAR THERMOMETER, MODEL ET-101A, Substantially Equivalent on 2008-09-17. Applicant: Sejoy Electronics & Instruments Co., Ltd..

Clearance details

Applicant: Sejoy Electronics & Instruments Co., Ltd.
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2008-08-04
Decision date: 2008-09-17
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Hangzhou, Zhejiang, 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.