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510(k) DEN100002

INFRASCANNER, MODEL 1000 by Infrascan, Inc. — Product Code OPT

Clearance Details

Decision: DENG (De Novo Granted)
Decision Date: December 13, 2011
Date Received: April 8, 2010
Clearance Type: Post-NSE
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Infrared Hematoma Detector
Device Class: Class II
Regulation Number: 882.1935
Review Panel: NE
Submission Type

To employ near-infrared spectroscopy that is intended to be used to evaluate suspected brain hematomas.