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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reduced- Montage Standard Electroencephalograph
510(k) Number K251726
Device Name SignalNED System (Model RE)
Applicant
Forest Devices, Inc.
100 S Commons
Suite 102
Pittsburgh,  PA  15212
Applicant Contact Carmelo Montalvo
Correspondent
Third Party Review Group, LLC
25 Independence Blvd.
Warren,  NJ  07059
Correspondent Contact Dave Yungvirt
Regulation Number882.1400
Classification Product Code
OMC  
Subsequent Product Codes
GXY   OLT   OLU  
Date Received06/05/2025
Decision Date 09/03/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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