510(k) K201843— Infrared ear and forehead thermometer, model YI-100

Substantially Equivalent

Wenzhou Yosun Medical Technology Co.,Ltd

Clearance details

Applicant: Wenzhou Yosun Medical Technology Co.,Ltd
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2020-07-06
Decision date: 2020-10-23
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.