MONITORING EAR THERMOMETER, MODEL BTM-D1A— 510(k) K062445

Substantially Equivalent

Rio Flexon Technology Co., Ltd.

FDA 510(k) clearance K062445 for MONITORING EAR THERMOMETER, MODEL BTM-D1A, Substantially Equivalent on 2007-02-16. Applicant: Rio Flexon Technology Co., Ltd..

Clearance details

Applicant: Rio Flexon Technology Co., Ltd.
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2006-08-22
Decision date: 2007-02-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jhonghe City Taipei County, 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.