DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM

Transducer, Ultrasonic, Diagnostic

EDAN INSTRUMENTS, INC.

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

Pre-market Notification Details

Device IDK110999
510k NumberK110999
Device Name:DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
ClassificationTransducer, Ultrasonic, Diagnostic
Applicant EDAN INSTRUMENTS, INC. 4/F, NEW ENERGY BLDG., 2009 NANYOU ROAD Nanshan, Guangdong,  CN 518054
ContactRandy Jiang
CorrespondentMarc M Mouser
UNDERWRITERS LABORATORIES, INC. 2600 NW LAKE RD. Camas,  WA  98607 -9526
Product CodeITX  
CFR Regulation Number892.1570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2011-04-11
Decision Date2011-04-26
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.