The following data is part of a premarket notification filed by Yibin Junxin Electronics Technology Co., Ltd. with the FDA for Infrared Thermometer, Models: Yrk-002a, T8, T9, T10, T11.
Device ID | K203662 |
510k Number | K203662 |
Device Name: | Infrared Thermometer, Models: YRK-002A, T8, T9, T10, T11 |
Classification | Thermometer, Electronic, Clinical |
Applicant | Yibin Junxin Electronics Technology Co., Ltd. Building B2, No. 136, West Section Of Xinggang Road, Lingang Economic And Technological Devel Yibin, CN 644000 |
Contact | Chaoze Guan |
Correspondent | Cassie Lee Share Info (Guangzhou) Medical Consultant Ltd. No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road, Huang District, Guangzhou, China Guangzhou, CN 510000 |
Product Code | FLL |
CFR Regulation Number | 880.2910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-12-15 |
Decision Date | 2021-09-23 |