The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for Td-1035 Thermometer.
Device ID | K172733 |
510k Number | K172733 |
Device Name: | TD-1035 Thermometer |
Classification | Thermometer, Electronic, Clinical |
Applicant | TaiDoc Technology Corporation B1-7F, No.127, Wugong 2nd Rd., Wugu District New Taipei City, TW 24888 |
Contact | Sheena Song |
Correspondent | Sheena Song TaiDoc Technology Corporation B1-7F, 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 | 2017-09-11 |
Decision Date | 2018-10-22 |