DIAGNOSTIC ULTRASOUND SYSTEM

System, Imaging, Pulsed Doppler, Ultrasonic

EDAN INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Edan Instruments, Inc. with the FDA for Diagnostic Ultrasound System.

Pre-market Notification Details

Device IDK123249
510k NumberK123249
Device Name:DIAGNOSTIC ULTRASOUND SYSTEM
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant EDAN INSTRUMENTS, INC. EQUIPMENTS PARK, NANHAI RD 1019 NO. SHEKOU NANSHAN Shenzhen,  CN 518067
ContactRandy Jiang
CorrespondentNed Devine
UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook,  IL  60062
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2012-10-17
Decision Date2013-02-08
Summary:summary

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