BELTER INFRA-RED EAR THERMOMETER— 510(k) K140681

Substantially Equivalent

Shenzhen Belter Health Measurement and Analysis TE

FDA 510(k) clearance K140681 for BELTER INFRA-RED EAR THERMOMETER, Substantially Equivalent on 2014-08-21. Applicant: Shenzhen Belter Health Measurement and Analysis TE.

Clearance details

Applicant: Shenzhen Belter Health Measurement and Analysis TE
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2014-03-18
Decision date: 2014-08-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, Guangdong, 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.