EAR THERMOMETER MODELS ST61, ST62, ST63, ST64, AND ST65— 510(k) K042627

Substantially Equivalent

Mesure Technology Co., Ltd.

FDA 510(k) clearance K042627 for EAR THERMOMETER MODELS ST61, ST62, ST63, ST64, AND ST65, Substantially Equivalent on 2004-10-18. Applicant: Mesure Technology Co., Ltd..

Clearance details

Applicant: Mesure Technology Co., Ltd.
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2004-09-27
Decision date: 2004-10-18
Decision: Substantially Equivalent
Clearance type: Special
Location: San Chung City, TW

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.