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 IDK102920
510k NumberK102920
Device Name:ELECTRONIC BLOOD PRESSURE MONITOR
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant SHENZHEN PANGO ELECTRONIC CO., LTD P.O. BOX 237-023 Shanghai,  CN 200030
ContactDiana Hong
CorrespondentNed Devine
UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook,  IL  60062
Product CodeDXN  
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2010-10-01
Decision Date2010-10-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06948423800408 K102920 000
00856324008310 K102920 000

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