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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 K103527
Device Name AVIATOR TRANSPORT INCUBATOR WITH MASIMO PULSEOX, AVIATOR TRANSPORT INCUBATOR WITH NELLCOR PULSEOX
Applicant
INTERNATIONAL BIOMEDICAL, LTD.
8508 CROSS PARK DR.
AUSTIN,  TX  78754
Applicant Contact AMY PIEPER
Correspondent
INTERNATIONAL BIOMEDICAL, LTD.
8508 CROSS PARK DR.
AUSTIN,  TX  78754
Correspondent Contact AMY PIEPER
Regulation Number880.5410
Classification Product Code
FPL  
Date Received12/01/2010
Decision Date 04/15/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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