DIGITAL ULTRASOUND SCANNER

System, Imaging, Pulsed Echo, Ultrasonic

SHENZHEN WELL.D MEDICAL ELECTRONICS CO., LTD

The following data is part of a premarket notification filed by Shenzhen Well.d Medical Electronics Co., Ltd with the FDA for Digital Ultrasound Scanner.

Pre-market Notification Details

Device IDK100079
510k NumberK100079
Device Name:DIGITAL ULTRASOUND SCANNER
ClassificationSystem, Imaging, Pulsed Echo, Ultrasonic
Applicant SHENZHEN WELL.D MEDICAL ELECTRONICS CO., LTD STE 5D NO.19, LANE 999, ZHONGSHAN NO. 2 ROAD(S) Shanghai,  CN 200030
ContactDiana Hong
CorrespondentMarc Mouser
UNDERWRITERS LABORATORIES, INC. 2600 NW LAKE RD. Camas,  WA  98607 -9526
Product CodeIYO  
CFR Regulation Number892.1560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2010-01-12
Decision Date2010-03-01
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06972174670034 K100079 000

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