Infrared Thermometer, models AOJ-20A, AOJ-20B, AOJ-20C, AOJ-20D, AOJ-20E, AOJ-20F, AOJ-20H, AOJ-20M, AOJ-20T, AOJ-20R and AOJ-20Y— 510(k) K221039

Substantially Equivalent

Shenzhen AOJ Medical Technology Co., Ltd.

FDA 510(k) clearance K221039 for Infrared Thermometer, models AOJ-20A, AOJ-20B, AOJ-20C, AOJ-20D, AOJ-20E, AOJ-20F, AOJ-20H, AOJ-20M, AOJ-20T, AOJ-20R and AOJ-20Y, Substantially Equivalent on 2022-12-20. 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: 2022-04-07
Decision date: 2022-12-20
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.