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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device cranial measurement software
Definition Cranial measurement software is intended to be used to calculate and display physical measurements of the head for interpretation by a qualified user in conjunction with other clinical methods.
Product CodeQQO
Regulation Number 878.4800
Device Class 1


Premarket Reviews
ManufacturerDecision
PEDIAMETRIX, INC.
  SUBSTANTIALLY EQUIVALENT 1

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