The following data is part of a premarket notification filed by Bioland Technology Ltd. with the FDA for Digital Thermometer Model T103, T104.
Device ID | K201879 |
510k Number | K201879 |
Device Name: | Digital Thermometer Model T103, T104 |
Classification | Thermometer, Electronic, Clinical |
Applicant | Bioland Technology Ltd. No. A6B7 (Block G) ShangRong Industrial Zone No. 5 Baolong R Shenzhen, CN 518116 |
Contact | Yiqing Feng |
Correspondent | Yiqing Feng Bioland Technology Ltd. No. A6B7 (Block G) ShangRong Industrial Zone No. 5 Baolong R Shenzhen, CN 518116 |
Product Code | FLL |
CFR Regulation Number | 880.2910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-07-07 |
Decision Date | 2021-03-31 |