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Sonotrax Series Ultrasonic Pocket Doppler Section 1
SPECIAL 510(K) DEVICE MODIFICATION

510(k) Summary of Safety and Effectiveness

This summary of 5 10k safety and effectiveness is being submitted in according with 2 1 CFR part
807.92
Submitter: Edan Instruments, Inc 3/F - B, Nanshan Medical 109 AGI 20 Equipments Park, Nanhai Rd119,AG1020 shekou, Nanshan Shenzhen, 518067 P.R. China Tel: 86-755-26882220 Fax:86-755-26 882223 Contact person: Yue Qiuhong
Official correspondent: William Stem Multigon Industries ,hic. I Odell Plaza Yonkers, N.Y. 10701 Phone: 914 376 5200 X27 Fax: 914 376 6111
Date of Preparation: 2010-6-21
Proprietary Name: Sonotrax Series Ultrasonic Pocket Doppler (Moclels:Sonotrax Lite, Sonotrax Basic, Pro, Sonotrax II , Sonotrax II Pro
Classification Name: 21 CFR 884.2660 Fetal ultrasonic monitor and accessories 21 CFR 884.2660 Ultrasonic Blood Flow Monitor
Product code: KNG REP
Device Description: The Sonotrax series Ultrasonic Pocket Doppler is a hand-held device for non-invasive measurement and display of fetal headt rate and blood flow velocity utilizing the principle of Doppler shift of an ultrasound. The
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