The following data is part of a premarket notification filed by Fudakang Industrial Co., Ltd with the FDA for Digital Thermometer.
| Device ID | K172121 |
| 510k Number | K172121 |
| Device Name: | Digital Thermometer |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | Fudakang Industrial Co., Ltd No. 8 Yinghe Road, Yuanjiangyuan Management Zone, Changping Town Dongguan, CN 523560 |
| Contact | Bob Yu |
| Correspondent | Field Fu Shenzhen Joyantech Consulting Co., Ltd NO. 55 Shizhou Middle Road , Nanshan District Shenzhen, CN Gd755 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-13 |
| Decision Date | 2018-06-07 |
| Summary: | summary |