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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 K173486
Device Name NTU-USB Ultrasound USB Box
Applicant
National Taiwan University
# 1, Sec. 4, Roosevelt Rd., Taipei 10617, Taiwan (R.O.C)
Taipei,  TW 10617
Applicant Contact Pai-Chi Li
Correspondent
National Taiwan University
# 1, Sec. 4, Roosevelt Rd., Taipei 10617, Taiwan (R.O.C)
Taipei,  TW 10617
Correspondent Contact Pai-Chi Li
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received11/13/2017
Decision Date 07/11/2018
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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