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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name transducer, ultrasonic, diagnostic
510(k) Number K122515
Device Name C2-9-D ULTRASOUND TRANSDUCER
Original Applicant
GE HEALTHCARE
9900 innovation drive
wauwatosa,  WI  53226
Original Contact bryan behn
Regulation Number892.1570
Classification Product Code
ITX  
Date Received08/17/2012
Decision Date 09/11/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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