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 Stimulator, Electrical, Evoked Response
510(k) Number K242345
Device Name Delphi Stimulator
Applicant
Quantalx Neuroscience
1 Hatachana St.
Kfar Sava,  IL 4453001
Applicant Contact Iftach Dolev
Correspondent
ProMedoss, Inc.
6026 Beech Cove Ln
Charlotte,  NC  28269
Correspondent Contact Bosmat Friedman-Cox
Regulation Number882.1870
Classification Product Code
GWF  
Date Received08/07/2024
Decision Date 11/05/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-