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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 Echo, Ultrasonic
510(k) Number K192791
Device Name Diagnostic Ultrasound System
Applicant
Edan Instruments, Inc.
15 Jinhui Rd., Jinsha Community, Kengzi Sub-District,
Pingshan District,
Shenzhen,  CN 518122
Applicant Contact Stella Guo
Correspondent
Edan Instruments, Inc.
15 Jinhui Rd., Jinsha Community, Kengzi Sub-District,
Pingshan District,
Shenzhen,  CN 518122
Correspondent Contact Stella Guo
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Codes
ITX   IYN  
Date Received09/30/2019
Decision Date 11/27/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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