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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 K102113
Device Name GE VENUE 40 COMPACT DIAGNOSTIC ULTRASOUND
Applicant
Ge Medical Systems China Co., Ltd.
# 19 Changjiang Rd.
National Hi-Tech Dev. Zone
Wuxi, Jiangsu Province,  CN 214028
Applicant Contact YALAN WU
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received07/28/2010
Decision Date 08/12/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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