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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 K830748
Device Name RESUSCITAIRE
Applicant
Vickers America Medical Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Vickers America Medical Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.5130
Classification Product Code
FMT  
Date Received03/09/1983
Decision Date 06/22/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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