Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Continuous Measurement Thermometer
510(k) Number K160544
Device Name Withings Thermo (Model SCT01)
Applicant
Withings
20 Rue Maurice Hartmann
Issy-Les-Moulineaux,  FR 921300
Applicant Contact Xavier Debreuil
Correspondent
Wincent Consultant Co., Ltd.
# 15, Alley 71, Cheping 1st St., Beitun District,
Taichung,  CN 406
Correspondent Contact Tony C.S. Chang
Regulation Number880.2910
Classification Product Code
FLL  
Date Received02/26/2016
Decision Date 06/17/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-