Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103)— 510(k) K250470

Substantially Equivalent

Shenzhen AOJ Medical Technology Co., Ltd.

FDA 510(k) clearance K250470 for Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103), Substantially Equivalent on 2025-06-23. Applicant: Shenzhen AOJ Medical Technology Co., Ltd..

Clearance details

Applicant: Shenzhen AOJ Medical Technology Co., Ltd.
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2025-02-18
Decision date: 2025-06-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, 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.