The following data is part of a premarket notification filed by Smart Technology Co., Ltd. with the FDA for Dt100 Digital Thermometer.
| Device ID | K203731 |
| 510k Number | K203731 |
| Device Name: | DT100 Digital Thermometer |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | Smart Technology Co., Ltd. No. 8 Xingcheng East Road, Fuwan Industrial Area, Gaoming District Foshan, CN 528500 |
| Contact | Meg Mei |
| Correspondent | Yulan Gao Guangzhou Osmunda Medical Device Technical Service Co., Ltd. 8-9th Floor, R&D Building, No.26 Qinglan Street, Panyu District Guangzhou, CN 510006 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-21 |
| Decision Date | 2021-09-26 |