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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device monitor, electric for gravity flow infusion systems
Regulation Description Electronic monitor for gravity flow infusion systems.
Product CodeFLN
Regulation Number 880.2420
Device Class 2


Premarket Reviews
ManufacturerDecision
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
EMTECH GMBH
  SUBSTANTIALLY EQUIVALENT 1
IMED CORP.
  SUBSTANTIALLY EQUIVALENT 4
NORTHGATE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1
THE JOHN BUNN CO.
  SUBSTANTIALLY EQUIVALENT 1

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