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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name transcranial magnetic stimulator
510(k) Number K173441
Device Name Neurosoft TMS (also CloudTMS)
27 Arlington Rd., Building 2, Unit 1
Woburn,  MA  01801
Applicant Contact Joe F. Jabre
Makromed, Inc.
88 Stiles Road
Salem,  NH  03079
Correspondent Contact Barry Ashar
Regulation Number882.5805
Classification Product Code
Date Received11/06/2017
Decision Date 12/13/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No