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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Doppler, Ultrasonic
510(k) Number K173003
Device Name U50 Diagnostic Ultrasound System
Applicant
Edan Instruments, Inc.
15 Jinhui Rd., Jinsha Community, Kengzi Sub-District,
Pingshan District,
Shenzhen,  CN 518122
Applicant Contact Alice Yang
Correspondent
Edan Medical
1200 Crossman Ave.
Suite 200
Sunnyvale,  CA  94089
Correspondent Contact Doug Worth
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received09/27/2017
Decision Date 11/15/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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