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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 K202119
Device Name AcuSee AS-P1000 System
Applicant
Weipeng (Suzhou) Medical Devices Co., Ltd.
Unit 207, Bldg. B2, Biobay, 218 Xinghu St.,
Suzhou Industrial Park
Suzhou,  CN 215123
Applicant Contact Bin Yang
Correspondent
Springborne Life Sciences
750 Menlo Ave.
Suite 200
Menlo Park,  CA  94025
Correspondent Contact Geetha Rao
Regulation Number892.1560
Classification Product Code
IYO  
Date Received07/30/2020
Decision Date 10/07/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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