5 SEC DIGITAL CLINICAL THERMOMETER, MODELS ST8630X, ST8640X, ST8730X, ST8740X, ST8930X, ST8940X, ST8030X, ST8040X.— 510(k) K050303

Substantially Equivalent

Mesure Technology Co., Ltd.

FDA 510(k) clearance K050303 for 5 SEC DIGITAL CLINICAL THERMOMETER, MODELS ST8630X, ST8640X, ST8730X, ST8740X, ST8930X, ST8940X, ST8030X, ST8040X., Substantially Equivalent on 2005-02-25. Applicant: Mesure Technology Co., Ltd..

Clearance details

Applicant: Mesure Technology Co., Ltd.
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2005-02-08
Decision date: 2005-02-25
Decision: Substantially Equivalent
Clearance type: Special
Location: San Chung City, TW

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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.