Infared Thermometer

Thermometer, Electronic, Clinical

Shenzhen Calibeur Industries Co., Ltd.

The following data is part of a premarket notification filed by Shenzhen Calibeur Industries Co., Ltd. with the FDA for Infared Thermometer.

Pre-market Notification Details

Device IDK191251
510k NumberK191251
Device Name:Infared Thermometer
ClassificationThermometer, Electronic, Clinical
Applicant Shenzhen Calibeur Industries Co., Ltd. No. 11 Bldg., Shiguan Industrial Park, Gongming, Guangming New District Shenzhen,  CN
ContactWeibin He
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 Received2019-05-09
Decision Date2019-10-15

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06970000910828 K191251 000
00810477022852 K191251 000
00810477022838 K191251 000
00810477023668 K191251 000
00810477023606 K191251 000
00810477023613 K191251 000
00810477022869 K191251 000
00810477022883 K191251 000
00810477021749 K191251 000
06970000910132 K191251 000
06970000910170 K191251 000
06970000910811 K191251 000
00810477022876 K191251 000

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