Electronic Blood Pressure Monitor

System, Measurement, Blood-pressure, Non-invasive

Shenzhen Pango Electronic Co., Ltd.

The following data is part of a premarket notification filed by Shenzhen Pango Electronic Co., Ltd. with the FDA for Electronic Blood Pressure Monitor.

Pre-market Notification Details

Device IDK200716
510k NumberK200716
Device Name:Electronic Blood Pressure Monitor
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant Shenzhen Pango Electronic Co., Ltd. No.25, 1st Industrial Park, Fenghuang Road Xikeng, Henggang, Longgang District Shenzhen,  CN 518115
ContactXioyun Yang
CorrespondentDiana Hong
Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai,  CN 200120
Product CodeDXN  
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-18
Decision Date2020-12-04

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
G467101112BC0 K200716 000

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