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510(k) K200203

Infrascanner by Infrascan, Inc. — Product Code OPT

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: July 10, 2020
Date Received: January 28, 2020
Clearance Type: Traditional
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.