The following data is part of a premarket notification filed by Alicn Medical Shenzhen, Inc. with the FDA for Electronic Thermometer, Model: Aet-f101, Aet-f221, Aet-f231, Aet-f241.
| Device ID | K210937 |
| 510k Number | K210937 |
| Device Name: | Electronic Thermometer, Model: AET-F101, AET-F221, AET-F231, AET-F241 |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | Alicn Medical Shenzhen, Inc. Room 410, Building A, 3rd Sub-Park, Leibo Zhongcheng Life Sci Pk., #22 Jinxiu Rd, Jinsha Comm., Kengzi St, Pingshan Shenzhen, CN 518118 |
| Contact | Fang Meisong |
| Correspondent | Renxiong Huang Alicn Medical Shenzhen, Inc. Room 410, Building A, 3rd Sub-Park, Leibo Zhongcheng Life Sci Pk., #22 Jinxiu Rd, Jinsha Comm., Kengzi St, Pingshan 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 | 2021-03-29 |
| Decision Date | 2022-05-12 |