U50 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 U50 Diagnostic Ultrasound System.

Pre-market Notification Details

Device IDK142511
510k NumberK142511
Device Name:U50 Diagnostic Ultrasound System
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant EDAN INSTRUMENTS, INC. 3/F-B, NANSHAN MEDICAL NANHAI RD1019#, Shekou, Nanshan Shenzhen,  CN 518067
ContactCherry Sun
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2014-09-08
Decision Date2015-02-20
Summary:summary

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