The following data is part of a premarket notification filed by Shenzhen Aoj Medical Technology Co., Ltd. with the FDA for Digital Thermometer, Models: Aoj-25a, Aoj-25b, Aoj-25c, Aoj-25d And Aoj-25e.
| Device ID | K213485 |
| 510k Number | K213485 |
| Device Name: | Digital Thermometer, Models: AOJ-25A, AOJ-25B, AOJ-25C, AOJ-25D And AOJ-25E |
| 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 District Shenzhen, CN 518126 |
| Contact | Queena Chen |
| Correspondent | Queena Chen Shenzhen AOJ Medical Technology Co., Ltd. Room 301&4F, Blk A, Building A, Jingfa IM Park Xiaweiyuan, Gushu Community, Xixiang, Baoan District 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 | 2021-10-29 |
| Decision Date | 2022-05-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06972040111456 | K213485 | 000 |
| 06972040112392 | K213485 | 000 |