Arm Type Blood Pressure Monitor, Digital Blood Pressure Monitor-Automatic Upper Arm Style

System, Measurement, Blood-pressure, Non-invasive

Shenzhen Combei Technology CO., LTD

The following data is part of a premarket notification filed by Shenzhen Combei Technology Co., Ltd with the FDA for Arm Type Blood Pressure Monitor, Digital Blood Pressure Monitor-automatic Upper Arm Style.

Pre-market Notification Details

Device IDK181104
510k NumberK181104
Device Name:Arm Type Blood Pressure Monitor, Digital Blood Pressure Monitor-Automatic Upper Arm Style
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant Shenzhen Combei Technology CO., LTD 11-5B No.105, Huanguan South Road, Dahe Community, Guanlan Guanlan, Shenzhen,  CN 518110
ContactKevin Fong
CorrespondentField Fu
Shenzhen Joyantech Consulting Co., Ltd 1122#, International Mayor Communication Center, Baishizhong Road 55# Nanshan District, Shenzhen,  CN 518000
Product CodeDXN  
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-04-26
Decision Date2018-08-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06948158404469 K181104 000
06948158404452 K181104 000
08906101765676 K181104 000
06948158401499 K181104 000
00616784709635 K181104 000

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