Reusable Temperature Probe

Thermometer, Electronic, Clinical

Shenzhen Caremed Medical Technology Co., Ltd.

The following data is part of a premarket notification filed by Shenzhen Caremed Medical Technology Co., Ltd. with the FDA for Reusable Temperature Probe.

Pre-market Notification Details

Device IDK182751
510k NumberK182751
Device Name:Reusable Temperature Probe
ClassificationThermometer, Electronic, Clinical
Applicant Shenzhen Caremed Medical Technology Co., Ltd. East Side, 3/F, C Building, Kelunte Low-Carbon Industries Gaofeng Community Dalang Office, Longhua District, Shenzhe,  CN 518109
ContactAlan Xie
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 Received2018-09-28
Decision Date2019-09-06
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06970758507721 K182751 000

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