The following data is part of a premarket notification filed by Withings with the FDA for Withings Thermo (model Sct01).
Device ID | K160544 |
510k Number | K160544 |
Device Name: | Withings Thermo (Model SCT01) |
Classification | Thermometer, Electronic, Clinical |
Applicant | WITHINGS 20 Rue Maurice Hartmann Issy-les-moulineaux, FR 921300 |
Contact | Xavier Debreuil |
Correspondent | Tony C.s. Chang Wincent Consultant Co., Ltd. No. 15, Alley 71, Cheping 1st St., Beitun District, Taichung, CN 406 |
Product Code | FLL |
CFR Regulation Number | 880.2910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-02-26 |
Decision Date | 2016-06-17 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04719873310067 | K160544 | 000 |
04719873310012 | K160544 | 000 |