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 Swbpm22 Series.
Device ID | K142088 |
510k Number | K142088 |
Device Name: | DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR SWBPM22 SERIES |
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 |
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 |
Product Code | DXN |
CFR Regulation Number | 870.1130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-08-01 |
Decision Date | 2014-10-31 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10845717006924 | K142088 | 000 |
00845717006484 | K142088 | 000 |