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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 K231889
Device Name Endoscopic Ultrasonic Diagnostic Equipment /Disposable Sterile Endoscopic Ultrasonic Probe (USW-S1,USW140-S20MS)
Applicant
Ultrasound Biotechnology (Shanghai) Co., Ltd.
Rm. 401, Floor 4, # 1 Bldg., 269 Lianchuang Rd.
Pudong
Shanghai,  CN 200135
Applicant Contact Yingnan Zhang
Correspondent
Ultrasound Biotechnology (Shanghai) Co., Ltd.
Rm. 401, Floor 4, # 1 Bldg., 269 Lianchuang Rd.
Pudong
Shanghai,  CN 200135
Correspondent Contact Yingnan Zhang
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Code
ITX  
Date Received06/27/2023
Decision Date 12/21/2023
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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