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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device analyzer, body composition
Regulation Description Impedance plethysmograph.
Product CodeMNW
Regulation Number 870.2770
Device Class 2


Premarket Reviews
ManufacturerDecision
AVITA CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
CHRISTINE VALMY INC
  SUBSTANTIALLY EQUIVALENT 1
FOOK TIN TECHNOLOGIES LIMITED
  SUBSTANTIALLY EQUIVALENT 1
HEALTH & LIFE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JAWON MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 5
NIHON SEIMITSU SOKKI CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
OMRON HEALTHCARE, INC.
  SUBSTANTIALLY EQUIVALENT 4

Device Problems
Burst 1
Total Device Problems 1

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