IR EAR/FOREHEAD THERMOMETER MODE DX6635, DX6637, DTH1081

Thermometer, Electronic, Clinical

SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.

The following data is part of a premarket notification filed by Shenzhen Dongdixin Technology Co, Ltd. with the FDA for Ir Ear/forehead Thermometer Mode Dx6635, Dx6637, Dth1081.

Pre-market Notification Details

Device IDK100488
510k NumberK100488
Device Name:IR EAR/FOREHEAD THERMOMETER MODE DX6635, DX6637, DTH1081
ClassificationThermometer, Electronic, Clinical
Applicant SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. ESTAE XILIXIAOBAIMANG Nanshan District, Shenzhen,  CN 518108
ContactZhigang Zhao
Product CodeFLL  
CFR Regulation Number880.2910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2010-02-19
Decision Date2010-07-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10311917199303 K100488 000
00845717010016 K100488 000
10891040702033 K100488 000
20891040701200 K100488 000
10891040701197 K100488 000
10041260367066 K100488 000
10036800398297 K100488 000
10021130771292 K100488 000
00080196406404 K100488 000
06926408700011 K100488 000
20075020053293 K100488 000
10614299013473 K100488 000
10767056189352 K100488 000
10767056185453 K100488 000
10767056182254 K100488 000
10767056182100 K100488 000
10767056131320 K100488 000
00816479015281 K100488 000
00075020054043 K100488 000
20311917010797 K100488 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.