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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 K221129
Device Name CloudTMS for OCD
Applicant
Teleemg, LLC
7304 Beverly Blvd., #357
Los Angeles,  CA  90036
Applicant Contact Joe F Jabre
Correspondent
Makromed, Inc.
88 Stiles Rd.
Salem,  NH  03079
Correspondent Contact Barry Ashar
Regulation Number882.5802
Classification Product Code
QCI  
Date Received04/18/2022
Decision Date 03/10/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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