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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name infrared hematoma detector
510(k) Number K211617
Device Name Infrascanner
Infrascan, Inc.
3508 Market Street
Philadelphia,  PA  19104
Applicant Contact Baruch Ben Dor
400 US-169
Minneapolis,  MN  55441
Correspondent Contact Angela Mallery
Regulation Number882.1935
Classification Product Code
Date Received05/26/2021
Decision Date 02/09/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No