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 Wbpm15 Series.
Device ID | K120673 |
510k Number | K120673 |
Device Name: | DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR WBPM15 SERIES |
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 | 2012-03-05 |
Decision Date | 2013-02-14 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04895045403604 | K120673 | 000 |