The following data is part of a premarket notification filed by Grandway Technology (shenzhen) Limited with the FDA for Digital Automatic Wrist Blood Pressure Monitor Md3900.
| Device ID | K151583 |
| 510k Number | K151583 |
| Device Name: | Digital Automatic Wrist Blood Pressure Monitor MD3900 |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED BLOCK 7, ZHU KENG INDUSTRIAL ZONE, PING SHAN DISTRICT, Shenzhen, CN 518118 |
| Contact | Patrick Chow |
| Correspondent | Patrick Chow GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED BLOCK 7, ZHU KENG INDUSTRIAL ZONE, PING SHAN 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 | 2015-06-11 |
| Decision Date | 2015-08-07 |