WIRELESS BODY TEMPERATURE MONITOR MODEL BTM-DIX SERIES (BTM-DIC,D,E,F,G & H)— 510(k) K100226

Substantially Equivalent

Rio Flexon Technology Co., Ltd.

FDA 510(k) clearance K100226 for WIRELESS BODY TEMPERATURE MONITOR MODEL BTM-DIX SERIES (BTM-DIC,D,E,F,G & H), Substantially Equivalent on 2010-03-18. Applicant: Rio Flexon Technology Co., Ltd..

Clearance details

Applicant: Rio Flexon Technology Co., Ltd.
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2010-01-25
Decision date: 2010-03-18
Decision: Substantially Equivalent
Clearance type: Special
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.