The following data is part of a premarket notification filed by Shenzhen Aoj Medical Technology Co., Ltd. with the FDA for Arm Blood Pressure Monitor, Models Aoj-30a, Aoj-30b, Aoj-30c, Aoj-30d, Aoj-30e, Aoj-30f And Aoj-30g.
| Device ID | K222125 |
| 510k Number | K222125 |
| Device Name: | Arm Blood Pressure Monitor, Models AOJ-30A, AOJ-30B, AOJ-30C, AOJ-30D, AOJ-30E, AOJ-30F And AOJ-30G |
| 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 | 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 | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-07-18 |
| Decision Date | 2022-12-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06972040110817 | K222125 | 000 |
| 00850021777043 | K222125 | 000 |
| 10810113574902 | K222125 | 000 |