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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device monitor, ultrasonic, fetal
Regulation Description Fetal ultrasonic monitor and accessories.
Product CodeKNG
Regulation Number 884.2660
Device Class 2


Premarket Reviews
ManufacturerDecision
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
EDAN INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 5
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1
HUNTLEIGH HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 1
KOVEN TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDASONICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDIANA CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN CREATIVE INDUSTRY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Balloon leak(s) 1
Deflation issue 1
Inflation issue 1
Tears, rips, holes in device, device material 1
Total Device Problems 4

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