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 | K163113 |
510k Number | K163113 |
Device Name: | Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series |
Classification | System, Measurement, Blood-pressure, Non-invasive |
Applicant | GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED BLOCK 7, ZHU KENG INDUSTRIAL ZONE, PING SHAN DISTRICT, Shenzhen, CN 518118 |
Contact | Patrick Chow |
Correspondent | Patrick Chow GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED BLOCK 7, ZHU KENG INDUSTRIAL ZONE, PING SHAN DISTRICT, Shenzhen, CN 518118 |
Product Code | DXN |
CFR Regulation Number | 870.1130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-11-07 |
Decision Date | 2017-01-19 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04895045403628 | K163113 | 000 |