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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Incubator, Neonatal Transport
510(k) Number K161918
Device Name SREE MRI Transport Incubator
Applicant
Advanced Imaging Research Dba Sree Medical Systems
P.O. Box 603220
Cleveland,  OH  44103
Applicant Contact RAVI SRINIVASAN
Correspondent
Advanced Imaging Research Dba Sree Medical Systems
P.O. Box 603220
Cleveland,  OH  44103
Correspondent Contact RAVI SRINIVASAN
Regulation Number880.5410
Classification Product Code
FPL  
Date Received07/13/2016
Decision Date 03/03/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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