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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 K201059
Device Name S60 Elite Series/S70 Series Digital Color Doppler Ultrasound System
Applicant
Sonoscape Medical Corp.
Room 201 & 202, 12th Building, Shenzhen Software Park Phase
II 1 Keji Middle 2nd Rd, Yuehai Subdistrict,Nanshan District
Shenzhen,  CN 518057
Applicant Contact Toki Wu
Correspondent
Sonoscape Medical Corp.
Room 201 & 202, 12th Building, Shenzhen Software Park Phase
II 1 Keji Middle 2nd Rd, Yuehai Subdistrict,Nanshan District
Shenzhen,  CN 518057
Correspondent Contact Toki Wu
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received04/21/2020
Decision Date 07/30/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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