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 |