The following data is part of a premarket notification filed by Grandway Technology (shenzhen) Limited with the FDA for Digital Automatic Blood Pressure Monitor Bpm18 Series.
Device ID | K133619 |
510k Number | K133619 |
Device Name: | DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM18 SERIES |
Classification | System, Measurement, Blood-pressure, Non-invasive |
Applicant | GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED ZHU KENG INDUSTRIAL ZONE PING SHAN, LONG GANG DISTRICT Shenshen, Guang Dong, CN 518118 |
Contact | Patrick Chow |
Correspondent | Patrick Chow GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED ZHU KENG INDUSTRIAL ZONE PING SHAN, LONG GANG DISTRICT Shenshen, 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 | 2013-11-25 |
Decision Date | 2014-03-05 |
Summary: | summary |