The following data is part of a premarket notification filed by Dongguan Hcs Electronics Co., Ltd with the FDA for Infrared Thermometer.
| Device ID | K172891 |
| 510k Number | K172891 |
| Device Name: | Infrared Thermometer |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | Dongguan HCS Electronics Co., Ltd Floor 4, Building 1, No.1 Longtan Road, Tangxia Town Dongguan, CN |
| Contact | Angel You |
| Correspondent | Jet Li Guangzhou LETA Testing Technology Co., Ltd 6F, No.1 TianTai Road, Science City, LuoGang District Guangzhou, CN |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-22 |
| Decision Date | 2018-03-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06953825909031 | K172891 | 000 |
| 06971463320032 | K172891 | 000 |