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 |