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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device incubator, neonatal transport
Regulation Description Neonatal transport incubator.
Product CodeFPL
Regulation Number 880.5410
Device Class 2


Premarket Reviews
ManufacturerDecision
ATOM MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 1
FERNO-WASHINGTON
  SUBSTANTIALLY EQUIVALENT 2
HILL-ROM, INC.
  SUBSTANTIALLY EQUIVALENT 1
INTERNATIONAL BIOMEDICAL
  SUBSTANTIALLY EQUIVALENT 7
LMT LAMMERS MEDICAL TECHNOLOGY GMBH
  SUBSTANTIALLY EQUIVALENT 2

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