The following data is part of a premarket notification filed by Shenzhen Everbest Machinery Industry Co., Ltd with the FDA for Infrared Thermometer Models: Dt-8806s, Dt-8807s.
| Device ID | K203170 |
| 510k Number | K203170 |
| Device Name: | Infrared Thermometer Models: DT-8806S, DT-8807S |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | Shenzhen Everbest Machinery Industry Co., LTD 19th Building, 5th Region, Baiwangxin Industrial Park, Songbai Rd., Baimang, Xili, Nanshan Shenzhen, CN 518108 |
| Contact | Deng Aiguo |
| Correspondent | Kevin Wang Chonconn Medical Device Consulting Co., Ltd. Room 508, Block C, No. 1029 Nanhai Avenue, Nanshan District Shenzhen, CN 518067 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-10-23 |
| Decision Date | 2021-04-16 |