K213485

Substantially Equivalent

Digital Thermometer, Models: AOJ-25A, AOJ-25B, AOJ-25C, AOJ-25D and AOJ-25E

Applicant: Shenzhen AOJ Medical Technology Co., Ltd.
Product code: FLL
Advisory panel: General Hospital
Date received: 2021-10-29
Decision date: 2022-05-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, 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.