The following data is part of a premarket notification filed by Sichuan Youkede Medical Equipment Co.,ltd with the FDA for Non-contact Infrared Thermometer (models Wl-301, Wl-501, Wl-601, Wl-701).
| Device ID | K210171 |
| 510k Number | K210171 |
| Device Name: | Non-contact Infrared Thermometer (Models WL-301, WL-501, WL-601, WL-701) |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | Sichuan YOUKEDE Medical Equipment Co.,Ltd 2F, North Wing, No.102 Building, Mianyang Export Processing Zone, No.261 East Section Of Feiyun Road, Mianyang Hi-Tech Mianyang, CN 621000 |
| Contact | Sukey Chia |
| Correspondent | Yolanda Lan Sichuan YOUKEDE Medical Equipment Co.,Ltd 2F, North Wing, No.102 Building, Mianyang Export Processing Zone, No.261 East Section Of Feiyun Road, Mianyang Hi-Tech Mianyang, CN 621000 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-22 |
| Decision Date | 2022-03-18 |