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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name coil, magnetic resonance, specialty
510(k) Number K113365
Device Name INFANT ARRAY
Original Applicant
ADVANCED IMAGING RESEARCH DBA SREE MEDICAL SYSTEMS
po box 603220
cleveland,  OH  44103
Original Contact ravi sprinivasan
Regulation Number892.1000
Classification Product Code
MOS  
Date Received11/15/2011
Decision Date 03/29/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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