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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 Stimulation System For Obsessive-Compulsive Disorder
510(k) Number K233742
Device Name CloudTMS Edge for OCD
Applicant
Teleemg, LLC
167 Poinsettia Pl
Los Angeles,  CA  90036
Applicant Contact Joe Jabre
Correspondent
Makromed, Inc.
88 Stiles Rd.
Salem,  NH  03079
Correspondent Contact Barry Ashar
Regulation Number882.5802
Classification Product Code
QCI  
Date Received11/22/2023
Decision Date 12/22/2023
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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