510(k) K182652— COCET Digital Thermometer (Models KFT-01/KFT-02/KFT-03/KFT-04/KFT-05/KFT-06/KFT-07/KFT-08/KFT-09/KFT-10

Substantially Equivalent

Kangfu Medical Equipment Factory

Clearance details

Applicant: Kangfu Medical Equipment Factory
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2018-09-24
Decision date: 2018-11-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yueqing City, 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.