NON-CONTACT FOREHEAD INFRARED THERMOMETER, MODEL DT-8806H, BODY INFRARED THERMOMETER, MODEL DT-8806 AND DIGITAL INFRARED

Thermometer, Electronic, Clinical

SHENZHEN EVERBEST MACHINERY INDUSTRY CO., LTD.

The following data is part of a premarket notification filed by Shenzhen Everbest Machinery Industry Co., Ltd. with the FDA for Non-contact Forehead Infrared Thermometer, Model Dt-8806h, Body Infrared Thermometer, Model Dt-8806 And Digital Infrared.

Pre-market Notification Details

Device IDK101736
510k NumberK101736
Device Name:NON-CONTACT FOREHEAD INFRARED THERMOMETER, MODEL DT-8806H, BODY INFRARED THERMOMETER, MODEL DT-8806 AND DIGITAL INFRARED
ClassificationThermometer, Electronic, Clinical
Applicant SHENZHEN EVERBEST MACHINERY INDUSTRY CO., LTD. 19TH BUILDING, 5TH REGION BAIWANGXIN IND. PK. SONGBAI RD Baimang Xili Nanshan Shenzhen,  CN
ContactDeng Aiguo
CorrespondentTamas Borsai
TUV RHEINLAND OF NORTH AMERICA, INC. 12 COMMERCE RD. Newton,  CT  06470
Product CodeFLL  
CFR Regulation Number880.2910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2010-06-21
Decision Date2010-07-06
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06951110988365 K101736 000
06951110988259 K101736 000
06951110980062 K101736 000

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