The following data is part of a premarket notification filed by Shenzhen Aoj Medical Technology Co., Ltd. with the FDA for Electronic Blood Pressure Monitor.
| Device ID | K191180 |
| 510k Number | K191180 |
| Device Name: | Electronic Blood Pressure Monitor |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | Shenzhen AOJ Medical Technology Co., Ltd. 601, 6th Floor, B2 Building, An'le Industrial Park #172 Hangcheng Avenue Shenzhen, CN 518126 |
| Contact | Qihuan Zhao |
| Correspondent | Qihuan Zhao Shenzhen AOJ Medical Technology Co., Ltd. 601, 6th Floor, B2 Building, An'le Industrial Park #172 Hangcheng Avenue 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 | 2019-05-02 |
| Decision Date | 2019-08-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06972040110251 | K191180 | 000 |
| 06972040110572 | K191180 | 000 |
| 06972040110596 | K191180 | 000 |
| 06972040110794 | K191180 | 000 |