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 K251210
Device Name Ampa One System (AMPA-001)
Applicant
Neuromodulatory Devices & Applications
501 W. Broadway
Suite 1025
San Diego,  CA  92101
Applicant Contact Don Vaughn
Correspondent
Avio Medtech Consulting
2300 Myrtle Ave.
Suite 200
St Paul,  MN  55114
Correspondent Contact Matthieu Kirkland
Regulation Number882.5805
Classification Product Code
OBP  
Date Received04/18/2025
Decision Date 06/27/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-