Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
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
-
-