The following data is part of a premarket notification filed by Shenzhen Aoj Medical Technology Co., Ltd. with the FDA for Forehead Thermometer, Models Aoj-f101, Aoj-f102, Aoj-f103, Aoj-f104 Aoj-f105, Aoj-f106, Aoj-f107.
| Device ID | K221170 |
| 510k Number | K221170 |
| Device Name: | Forehead Thermometer, Models AOJ-F101, AOJ-F102, AOJ-F103, AOJ-F104 AOJ-F105, AOJ-F106, AOJ-F107 |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | Shenzhen AOJ Medical Technology Co., Ltd. Room 301&4F, Blk A, Building A, Jingfa IM Park Xiaweiyuan, Gushu Community, Xixiang, Baoan Shenzhen, CN 518126 |
| Contact | Jack Wang |
| Correspondent | Jack Wang Shenzhen AOJ Medical Technology Co., Ltd. Room 301&4F, Blk A, Building A, Jingfa IM Park Xiaweiyuan, Gushu Community, Xixiang, Baoan Shenzhen, CN 518126 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-04-22 |
| Decision Date | 2022-10-07 |