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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 K210317
Device Name Apogee 1000/ Apogee 1000Neo/ Apogee 1000Lite/ Apogee 1000Exp/ Apogee 1000B/W / Apogee 1U/ Apogee 1T/ Apogee 1G Digital Color Doppler Ultrasound Imaging System
Applicant
Shantou Institute of Ultrasonic Instruments Co., Ltd. (SIUI)
77 Jinsha Road
Shantou,  CN 515041
Applicant Contact Flower Cai
Correspondent
Shantou Institute of Ultrasonic Instruments Co., Ltd. (SIUI)
77 Jinsha Road
Shantou,  CN 515041
Correspondent Contact Flower Cai
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received02/03/2021
Decision Date 08/19/2021
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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