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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Amplifier, Physiological Signal
510(k) Number K242832
Device Name NExT Station; NExT Station Advanced
Applicant
Eb Neuro S.P.A.
Via P. Fanfani 97/A
Firenze,  IT 50127
Applicant Contact Marco Rossi
Correspondent
Makromed, Inc.
88 Stiles Rd.
Salem,  NH  03079
Correspondent Contact Barry Ashar
Regulation Number882.1835
Classification Product Code
GWL  
Subsequent Product Codes
GWE   GWF   GWJ   IKN   OLT  
Date Received09/19/2024
Decision Date 12/12/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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