The following data is part of a premarket notification filed by Grandway Technology (shenzhen) Limited with the FDA for Digital Automatic Blood Pressure Monitor Bpm41 Series, Digital Automatic Blood Pressure Monitor Bpm45 Series.
| Device ID | K163648 |
| 510k Number | K163648 |
| Device Name: | Digital Automatic Blood Pressure Monitor BPM41 Series, Digital Automatic Blood Pressure Monitor BPM45 Series |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | Grandway Technology (Shenzhen) Limited Block 7, Zhu Keng Industrial Zone, Ping Shan, Long Gang District, Shenzhen, CN 518118 |
| Contact | Patrick Chow |
| Correspondent | Patrick Chow Grandway Technology (Shenzhen) Limited Block 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 | 2016-12-23 |
| Decision Date | 2017-07-07 |
| Summary: | summary |