The following data is part of a premarket notification filed by Grandway Technology (shenzhen) Limited with the FDA for Digital Automatic Blood Pressure Monitor Bpm03 Series Model Md03x0.
| Device ID | K123073 |
| 510k Number | K123073 |
| Device Name: | DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM03 SERIES MODEL MD03X0 |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED Building 7, Zhu Keng Industrial Zone, Ping Shan, Long Gang District Shenzhen, CN 518118 |
| Contact | Patrick Chow |
| Correspondent | Patrick Chow GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED Building 7, Zhu Keng Industrial Zone, Ping Shan, Long Gang District Shenzhen, 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 | 2012-10-01 |
| Decision Date | 2013-03-11 |
| Summary: | summary |