The following data is part of a premarket notification filed by Xiamen Ants Bro Technology Co., Ltd. with the FDA for Infrared Forehead Thermometer.
| Device ID | K190984 |
| 510k Number | K190984 |
| Device Name: | Infrared Forehead Thermometer |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | Xiamen Ants Bro Technology Co., Ltd. 4th & 5th Floor, No.5 Building, Tech & Innovation Center No. 289 Wengjiao Road, Haicang District Xiamen, CN 361026 |
| Contact | Jane Xu |
| Correspondent | Cassie Lee Guangzhou GLOMED Biological Technology Co., Ltd. 2231, Building 1, Rui Feng Center, Kaichuang Road Huangpu District Guangzhou, CN 510000 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-15 |
| Decision Date | 2020-04-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06947707701356 | K190984 | 000 |
| 06947707701394 | K190984 | 000 |
| 06947707701400 | K190984 | 000 |
| 00853483008250 | K190984 | 000 |
| 00840423500523 | K190984 | 000 |