DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR WBPM22 SERIES

System, Measurement, Blood-pressure, Non-invasive

GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED

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 Wbpm22 Series.

Pre-market Notification Details

Device IDK133618
510k NumberK133618
Device Name:DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR WBPM22 SERIES
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED ZHU KENG INDUSTRIAL ZONE PING SHAN, LONG GANG DISTRICT Shenshen, Guang Dong,  CN 518118
ContactPatrick Chow
CorrespondentPatrick Chow
GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED ZHU KENG INDUSTRIAL ZONE PING SHAN, LONG GANG DISTRICT Shenshen, Guang Dong,  CN 518118
Product CodeDXN  
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-11-25
Decision Date2014-03-05
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04895045403642 K133618 000
04895045403635 K133618 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.