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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device monitor, pressure, intrauterine
Regulation Description Intrauterine pressure monitor and accessories.
Product CodeKXO
Regulation Number 884.2700
Device Class 2


Premarket Reviews
ManufacturerDecision
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1
HEWLETT-PACKARD CO.
  SUBSTANTIALLY EQUIVALENT 1
MEDEX
  SUBSTANTIALLY EQUIVALENT 3
UTAH MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 2

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