Upper Arm Type Blood Pressure Monitor

System, Measurement, Blood-pressure, Non-invasive

Shenzhen Jamr Technology Co.,Ltd

The following data is part of a premarket notification filed by Shenzhen Jamr Technology Co.,ltd with the FDA for Upper Arm Type Blood Pressure Monitor.

Pre-market Notification Details

Device IDK220886
510k NumberK220886
Device Name:Upper Arm Type Blood Pressure Monitor
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant Shenzhen Jamr Technology Co.,Ltd A101-301,D101-201, Jamr Science & Technology Park, No. 2 Guiyuan Road, Guixiang Community Shenzhen,  CN 518100
ContactLuo Fusheng
CorrespondentReanny Wang
Shenzhen Reanny Medical Devices Management Consulting Co Ltd Room 1407, Jingting Building, Dongzhou Community, Guangming Street, Guangming District Shenzhen,  CN 518000
Product CodeDXN  
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-03-28
Decision Date2022-07-27

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00863398000225 K220886 000
10810113577569 K220886 000
06927709401966 K220886 000
06927709400976 K220886 000

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