NON-CONTACT INFRARED THERMOMETER— 510(k) K130231

Substantially Equivalent

Jinxinbao Electronic Co.,Ltd

FDA 510(k) clearance K130231 for NON-CONTACT INFRARED THERMOMETER, Substantially Equivalent on 2013-10-15. Applicant: Jinxinbao Electronic Co.,Ltd.

Clearance details

Applicant: Jinxinbao Electronic Co.,Ltd
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2013-01-29
Decision date: 2013-10-15
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Wenzhou, Zhejiang, CN

Download summary PDF View on FDA.gov ↗

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.