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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 K963058
Device Name INFANT WARMER SYSTEM
Applicant
Ohmeda Medical
9065 Guilford Rd.
Columbia,  MD  21046
Applicant Contact ALBERTO F PROFUMO
Correspondent
Ohmeda Medical
9065 Guilford Rd.
Columbia,  MD  21046
Correspondent Contact ALBERTO F PROFUMO
Regulation Number880.5130
Classification Product Code
FMT  
Date Received08/06/1996
Decision Date 10/01/1996
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
Recalls CDRH Recalls
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