DIGITAL THERMOMETER (WITH DISPOSABLE THERMOMETER COVER), DT SERIES

Thermometer, Electronic, Clinical

HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO.,

The following data is part of a premarket notification filed by Hangzhou Hua'an Medical & Health Instruments Co., with the FDA for Digital Thermometer (with Disposable Thermometer Cover), Dt Series.

Pre-market Notification Details

Device IDK092447
510k NumberK092447
Device Name:DIGITAL THERMOMETER (WITH DISPOSABLE THERMOMETER COVER), DT SERIES
ClassificationThermometer, Electronic, Clinical
Applicant HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO., BLDG 2, BAIMIAO IND. PARK ECONOMIC DEVELOPMENT ZONE Wuchang, Hangzhou, Zhejiang,  CN 310023
ContactJi Bo
CorrespondentJi Bo
HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO., BLDG 2, BAIMIAO IND. PARK ECONOMIC DEVELOPMENT ZONE Wuchang, Hangzhou, Zhejiang,  CN 310023
Product CodeFLL  
CFR Regulation Number880.2910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-08-10
Decision Date2010-01-07

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00616784561134 K092447 000
00616784561035 K092447 000

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