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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 K220742
Device Name NxtGen Infant Transport Incubator
Applicant
International Biomedical
8206 Cross Park Drive
Austin,  TX  78754
Applicant Contact Amy Pieper
Correspondent
International Biomedical
8206 Cross Park Drive
Austin,  TX  78754
Correspondent Contact Amy Pieper
Regulation Number880.5410
Classification Product Code
FPL  
Date Received03/14/2022
Decision Date 07/15/2022
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
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