Withings Thermo (Model SCT01)

Thermometer, Electronic, Clinical

WITHINGS

The following data is part of a premarket notification filed by Withings with the FDA for Withings Thermo (model Sct01).

Pre-market Notification Details

Device IDK160544
510k NumberK160544
Device Name:Withings Thermo (Model SCT01)
ClassificationThermometer, Electronic, Clinical
Applicant WITHINGS 20 Rue Maurice Hartmann Issy-les-moulineaux,  FR 921300
ContactXavier Debreuil
CorrespondentTony C.s. Chang
Wincent Consultant Co., Ltd. No. 15, Alley 71, Cheping 1st St., Beitun District, Taichung,  CN 406
Product CodeFLL  
CFR Regulation Number880.2910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-02-26
Decision Date2016-06-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04719873310067 K160544 000
04719873310012 K160544 000

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