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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 K241389
Device Name Infrascanner Model 2500 (Model 2500)
Applicant
Infrascan, Inc.
3508 Market Street, Suite 127
Philadelphia,  PA  19104
Applicant Contact Baruch Ben Dor
Correspondent
Infrascan, Inc.
3508 Market Street, Suite 127
Philadelphia,  PA  19104
Correspondent Contact Baruch Ben Dor
Regulation Number882.1935
Classification Product Code
OPT  
Date Received05/15/2024
Decision Date 12/12/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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