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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 K001019
Device Name TI500 GLOBE-TROTTER TRANSPORT SYSTEM
Applicant
HILL-ROM AIR-SHIELDS
330 JACKSONVILLE RD.
HATBORO,  PA  19040
Applicant Contact JAMES G CARPENTER
Correspondent
HILL-ROM AIR-SHIELDS
330 JACKSONVILLE RD.
HATBORO,  PA  19040
Correspondent Contact JAMES G CARPENTER
Regulation Number880.5410
Classification Product Code
FPL  
Date Received03/30/2000
Decision Date 04/27/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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