510(k) K203662— Infrared thermometer, Models: YRK-002A, T8, T9, T10, T11

Substantially Equivalent

Yibin Junxin Electronics Technology Co., Ltd.

Clearance details

Applicant: Yibin Junxin Electronics Technology Co., Ltd.
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2020-12-15
Decision date: 2021-09-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yibin, 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.