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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 K152165
Device Name S9 Portable Digital Color Doppler Ultrasound System
Applicant
SONOSCAPE MEDICAL CORP.
4/f, 5/f, 8/f, 9/f & 10/f, Yizhe Building,
Yuquan Road, Nanshan
Shenzhen,  CN 518051
Applicant Contact Toki Wu
Correspondent
SONOSCAPE MEDICAL CORP.
4/f, 5/f, 8/f, 9/f & 10/f, Yizhe Building,
Yuquan Road, Nanshan
Shenzhen,  CN 518051
Correspondent Contact Toki Wu
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received08/03/2015
Decision Date 08/26/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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