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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Image-Intensified Fluoroscopic X-Ray System, Mobile
510(k) Number K163429
Device Name B6
Applicant
Beijing East Whale Imaging Technology Co., Ltd
Unit701, Building1, Yongchang Industrial Park
No.3 Yongchang North Rd., BDA
Beijing,  CN 100176
Applicant Contact Sharon Fan
Correspondent
Beijing East Whale Imaging Technology Co., Ltd
Unit701, Building1, Yongchang Industrial Park
No.3 Yongchang North Rd., BDA
Beijing,  CN 100176
Correspondent Contact Sharon Fan
Regulation Number892.1650
Classification Product Code
OXO  
Subsequent Product Code
JAA  
Date Received12/07/2016
Decision Date 01/04/2017
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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