The following data is part of a premarket notification filed by Shenzhen Aoj Medical Technology Co., Ltd. with the FDA for Wrist Blood Pressure Monitor, Models Aoj-35a, Aoj-35b, Aoj-35c, Aoj-35d, Aoj-35e.
| Device ID | K213503 |
| 510k Number | K213503 |
| Device Name: | Wrist Blood Pressure Monitor, Models AOJ-35A, AOJ-35B, AOJ-35C, AOJ-35D, AOJ-35E |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| 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 | 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 Shenzhen, CN 518126 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-11-01 |
| Decision Date | 2022-02-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06972040112545 | K213503 | 000 |
| 06972040112538 | K213503 | 000 |
| 10845717011027 | K213503 | 000 |
| 00810110303492 | K213503 | 000 |