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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name warmer, infant radiant
510(k) Number K121625
Models 2050878-001, 2061755-001
Device Name LULLABY TM WARMER
Original Applicant
WIPRO GE HEALTHCARE PRIVATE, LTD.
8880 goman road
laurel,  MD  20723 5800
Original Contact agata anthony
Regulation Number880.5130
Classification Product Code
FMT  
Date Received06/01/2012
Decision Date 09/14/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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