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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscope, Accessories, Narrow Band Spectrum
510(k) Number K173921
Device Name HD-500 Video Endoscope System
Applicant
Sonoscape Medical Corp.
4/F, 5/F, 8/F, 9/F & 10/F
Yizhe Bldg., Yuquan Rd., Nanshan
Shenzhen,  CN 518051
Applicant Contact Toki Wu
Correspondent
Mid-Link Consulting Co, Ltd.
P.O. Box 120-119
Shanghai,  CN 200120
Correspondent Contact Diana Hong
Regulation Number876.1500
Classification Product Code
NWB  
Subsequent Product Codes
FDF   FDS  
Date Received12/26/2017
Decision Date 09/05/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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