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 stimulator
510(k) Number K210201
Device Name Deep Transcranial Magnetic Stimulation (DTMS) System
Applicant
Brainsway Ltd.
19 Hartom St. (Bynet Bldg) Har Hotzvim
Jerusalem,  IL 9777518
Applicant Contact Ahava Stein
Correspondent
A. Stein-Regulatort Affairs Consulting Ltd.
18 Hata'as Str., Suite 21
Kfar Saba,  IL 4442520
Correspondent Contact Ahava Stein
Regulation Number882.5805
Classification Product Code
OBP  
Date Received01/25/2021
Decision Date 08/17/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-