The following data is part of a premarket notification filed by Alicn Medical Shenzhen, Inc. with the FDA for Electronic Thermometer, Model: Aet-e201, Aet-e211, Aet-e221, Aet-e231, Aet-e241, Aet-e251, Aet-e301, Aet-e311.
| Device ID | K212257 |
| 510k Number | K212257 |
| Device Name: | Electronic Thermometer, Model: AET-E201, AET-E211, AET-E221, AET-E231, AET-E241, AET-E251, AET-E301, AET-E311 |
| 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 | 2021-07-19 |
| Decision Date | 2022-05-04 |