DIGITAL THERMOMETER (WITH DISPOSABLE THERMOMETER COVER)— 510(k) K122912

Substantially Equivalent

Hangzhou Hua'An Medical & Health Instruments Co.,

FDA 510(k) clearance K122912 for DIGITAL THERMOMETER (WITH DISPOSABLE THERMOMETER COVER), Substantially Equivalent on 2012-11-07. Applicant: Hangzhou Hua'An Medical & Health Instruments Co.,.

Clearance details

Applicant: Hangzhou Hua'An Medical & Health Instruments Co.,
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2012-09-21
Decision date: 2012-11-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Wuchang, Hangzhou, 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.