Disposable Temperature Probe

Thermometer, Electronic, Clinical

Shenzhen Changke Connect Electronics Co., Ltd.

The following data is part of a premarket notification filed by Shenzhen Changke Connect Electronics Co., Ltd. with the FDA for Disposable Temperature Probe.

Pre-market Notification Details

Device IDK193625
510k NumberK193625
Device Name:Disposable Temperature Probe
ClassificationThermometer, Electronic, Clinical
Applicant Shenzhen Changke Connect Electronics Co., Ltd. A2-4th Floor Of Xiang Dali Technology Park No.87 Of HengPing Road, Henggang, Longgang District Shenzhen,  CN 518000
ContactYahui Zhou
CorrespondentKevin Wang
Chonconn Medical Device Consulting Co., Ltd. No. A415, Block A, NanShan Medical Devices Industrial Park Nanshan District Shenzhen,  CN 518067
Product CodeFLL  
CFR Regulation Number880.2910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-26
Decision Date2020-07-24

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