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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 K142982
Device Name OPUS 5100 Diagnostic Doppler Ultrasound System
Applicant
Chang Gung Medical Technology Co., Ltd.
11f., # 201-4, Dunhua N. Rd. Songshan Dist
Taipei City,  TW 10508
Applicant Contact CHENG MING CHEN
Correspondent
Leiker Regulatory & Quality Consulting
4157 N. Del Rey Ave.
Clovis,  CA  93619
Correspondent Contact BOB LEIKER
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received10/15/2014
Decision Date 09/03/2015
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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