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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 Road
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
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