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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 K242306
Device Name SignalNED System (Model RE)
Applicant
Forest Devices, Inc.
544 Miltenberger St.
1st Floor, #4
Pittsburgh,  PA  15219
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  
Date Received08/05/2024
Decision Date 09/04/2024
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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