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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device infrared hematoma detector
Definition To employ near-infrared spectroscopy that is intended to be used to evaluate suspected brain hematomas.
Product CodeOPT
Regulation Number 882.1935
Device Class 2


Premarket Reviews
ManufacturerDecision
INFRASCAN, INC.
  GRANTED 1
  SUBSTANTIALLY EQUIVALENT 3

Recalls
Manufacturer Recall Class Date Posted
1 Cutera, Inc. II Dec-09-2013
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