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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
Recalls CDRH Recalls
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