The following data is part of a premarket notification filed by Grandway Technology (shenzhen) Limited with the FDA for Digital Automatic Blood Pressure Monitor Bpm28 Series - Md2800, Md2810.
| Device ID | K143734 |
| 510k Number | K143734 |
| Device Name: | Digital Automatic Blood Pressure Monitor BPM28 Series - MD2800, MD2810 |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED Block 6 And 7, Zhu Keng Industrial Zone, Ping Shan Long Gang District Shenzhen, Guang Dong, CN 518118 |
| Contact | Patrick Chow |
| Correspondent | Patrick Chow GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED Block 6 And 7, Zhu Keng Industrial Zone, Ping Shan Long Gang District Shenzhen, Guang Dong, CN 518118 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-30 |
| Decision Date | 2015-05-02 |
| Summary: | summary |