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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device monitor, uterine contraction, external (for use in clinic)
Regulation Description External uterine contraction monitor and accessories.
Product CodeHFM
Regulation Number 884.2720
Device Class 2


Premarket Reviews
ManufacturerDecision
AMERICAN I.V. PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
INTERNATIONAL BIOMEDICAL
  SUBSTANTIALLY EQUIVALENT 1
UTAH MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
VENTREX, INC.
  SUBSTANTIALLY EQUIVALENT 2

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