The following data is part of a premarket notification filed by Alicn Medical Shenzhen, Inc with the FDA for Infrared Thermometer.
| Device ID | K210564 |
| 510k Number | K210564 |
| Device Name: | Infrared Thermometer |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | Alicn Medical Shenzhen, Inc Room 410, Building A, 3rd Sub-park, Leibo Zhongcheng Life Science Park, Kengzi Shenzhen, CN 518118 |
| Contact | Fang Meisong |
| Correspondent | Fang Meisong Alicn Medical Shenzhen,Inc Room 410, Building A, 3rd Sub-park, Leibo Zhongcheng Life Science Park, Kengzi Shenzhen, CN 518118 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-25 |
| Decision Date | 2022-01-07 |