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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 K121384
Model 7348
Device Name MYLABSOGNO
Original Applicant
ESAOTE, S.P.A.
9001 wesleyan road
suite 200
indianapolis,  IN  46268
Original Contact allison scott, rac
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Code
IYO  
Date Received05/08/2012
Decision Date 05/23/2012
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
Recalls CDRH Recalls
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