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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 K173058
Device Name P10 Series Digital Color Doppler Ultrasound 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
Sonoscape Medical Corp.
4/F, 5/F, 8/F, 9/F & 10/F
Yizhe Bldg., Yuquan Rd., Nanshan
Shenzhen,  CN 518051
Correspondent Contact Toki Wu
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received09/28/2017
Decision Date 12/01/2017
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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