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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 K233841
Device Name HD80 Series Ultrasound Diagnostic System
Applicant
Qingdao Hisense Medical Equipment Co., Ltd.
# 399 Songling Rd., Laoshan District
Qingdao, Shandong,  CN 266100
Applicant Contact Yalan Wu
Correspondent
Qingdao Hisense Medical Equipment Co., Ltd.
# 399 Songling Rd., Laoshan District
Qingdao, Shandong,  CN 266100
Correspondent Contact Yalan Wu
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received12/04/2023
Decision Date 05/16/2024
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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