The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for Clever Forehead Thermometer / Clever Medical Forehead Thermometer (model Td-1241).
Device ID | K200946 |
510k Number | K200946 |
Device Name: | Clever Forehead Thermometer / Clever Medical Forehead Thermometer (Model TD-1241) |
Classification | Thermometer, Electronic, Clinical |
Applicant | TaiDoc Technology Corporation 6F, No.127, Wugong 2nd Rd., Wugu District New Taipei City, TW 24888 |
Contact | Jacky Chou |
Correspondent | Jacky Chou TaiDoc Technology Corporation 6F, No.127, Wugong 2nd Rd., Wugu District New Taipei City, TW 24888 |
Product Code | FLL |
CFR Regulation Number | 880.2910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-04-08 |
Decision Date | 2022-04-05 |