CONTEC08A Electronic Sphygmomanometer, CONTEC08C Electronic Sphygmomanometer, ABPM50 Automatic Blood Pressure Monitor

System, Measurement, Blood-pressure, Non-invasive

Contec Medical Systems Co., Ltd.

The following data is part of a premarket notification filed by Contec Medical Systems Co., Ltd. with the FDA for Contec08a Electronic Sphygmomanometer, Contec08c Electronic Sphygmomanometer, Abpm50 Automatic Blood Pressure Monitor.

Pre-market Notification Details

Device IDK202757
510k NumberK202757
Device Name:CONTEC08A Electronic Sphygmomanometer, CONTEC08C Electronic Sphygmomanometer, ABPM50 Automatic Blood Pressure Monitor
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant Contec Medical Systems Co., Ltd. No.112 Qinhuang West Street, Economic & Technical Development Zone Hebei Province,  CN 066004
ContactXueyong Li
CorrespondentRay Wang
Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, Beijing,  CN 102401
Product CodeDXN  
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-21
Decision Date2021-04-28

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