MONITORING EAR THERMOMETER, MODEL BTM-D1A

Thermometer, Electronic, Clinical

RIO FLEXON TECHNOLOGY CO., LTD.

The following data is part of a premarket notification filed by Rio Flexon Technology Co., Ltd. with the FDA for Monitoring Ear Thermometer, Model Btm-d1a.

Pre-market Notification Details

Device IDK062445
510k NumberK062445
Device Name:MONITORING EAR THERMOMETER, MODEL BTM-D1A
ClassificationThermometer, Electronic, Clinical
Applicant RIO FLEXON TECHNOLOGY CO., LTD. 15F,868-2, JHONG JHENG RD., Jhonghe City Taipei County,  TW 235
ContactJeff Liao
CorrespondentJeff Liao
RIO FLEXON TECHNOLOGY CO., LTD. 15F,868-2, JHONG JHENG RD., Jhonghe City Taipei County,  TW 235
Product CodeFLL  
CFR Regulation Number880.2910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-08-22
Decision Date2007-02-16
Summary:summary

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