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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 K120642
Device Name RESUSCITAIRE WITH AUTOBREATH
Applicant
Draeger Medical Systems, Inc.
3135 QUARRY RD.
TELFORD,  PA  18969
Applicant Contact GALE WINARSKY
Correspondent
Draeger Medical Systems, Inc.
3135 QUARRY RD.
TELFORD,  PA  18969
Correspondent Contact GALE WINARSKY
Regulation Number880.5130
Classification Product Code
FMT  
Date Received03/02/2012
Decision Date 11/02/2012
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
Recalls CDRH Recalls
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