Electronic Thermometer (XHF2001, XHF2002)

Thermometer, Electronic, Clinical

Putian Hanjiang Huafeng Plastic Co., Ltd.

The following data is part of a premarket notification filed by Putian Hanjiang Huafeng Plastic Co., Ltd. with the FDA for Electronic Thermometer (xhf2001, Xhf2002).

Pre-market Notification Details

Device IDK211352
510k NumberK211352
Device Name:Electronic Thermometer (XHF2001, XHF2002)
ClassificationThermometer, Electronic, Clinical
Applicant Putian Hanjiang Huafeng Plastic Co., Ltd. 40M Road, Jiangkou Town, Hanjiang District Putian,  CN 351111
ContactYiqian Deng
CorrespondentRay Wang
Beijing Believe-Med Technology Service Co., Ltd Rm. 912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District Beijing,  CN 102401
Product CodeFLL  
CFR Regulation Number880.2910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-05-03
Decision Date2021-09-09

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