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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Incubator, Neonatal Transport
510(k) Number K141565
Device Name GLOBE-TROTTER GT5400
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 Number880.5410
Classification Product Code
FPL  
Date Received06/12/2014
Decision Date 09/10/2014
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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