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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 K003335
FOIA Releasable 510(k) K003335
Device Name RESUSCITAIRE RADIANT WARMER; RESUSCITAIRE BIRTHING ROOM WARMER; RESUSCITAIR WALL MOUNTED RADIANT WARMER
Applicant
HILL-ROM AIR-SHIELDS
330 JACKSONVILLE RD.
HATBORO,  PA  19040
Applicant Contact LARRY W KRASLEY
Correspondent
HILL-ROM AIR-SHIELDS
330 JACKSONVILLE RD.
HATBORO,  PA  19040
Correspondent Contact LARRY W KRASLEY
Regulation Number880.5130
Classification Product Code
FMT  
Date Received10/25/2000
Decision Date 11/17/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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