DIGITAL PACIFIER THERMOMETER (MODEL NO.: TM-03)— 510(k) K120671

Substantially Equivalent

Cotronic Technology Limited

FDA 510(k) clearance K120671 for DIGITAL PACIFIER THERMOMETER (MODEL NO.: TM-03), Substantially Equivalent on 2013-05-17. Applicant: Cotronic Technology Limited.

Clearance details

Applicant: Cotronic Technology Limited
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2012-03-05
Decision date: 2013-05-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shen Zhen, Guang Dong, 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.