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 Md2400.
Device ID | K143733 |
510k Number | K143733 |
Device Name: | Digital Automatic Wrist Blood Pressure Monitor MD2400 |
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, 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, 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 | 2015-04-03 |
Summary: | summary |