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 K212723
Device Name BTL-995-rTMS
Applicant
BTL Industries Inc.
362 Elm Street
Marlborough,  MA  01752
Applicant Contact David Chmel
Correspondent
BTL Industries Inc.
362 Elm Street
Marlborough,  MA  01752
Correspondent Contact David Chmel
Regulation Number882.5805
Classification Product Code
OBP  
Date Received08/27/2021
Decision Date 03/04/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-