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 Electrode, Cortical
510(k) Number K242618
Device Name Layer 7-T
Applicant
Precision Neuroscience, Corp.
319 N Bernardo Ave., Suite 157
Mountain View,  CA  94043
Applicant Contact Shruti Jayakumar
Correspondent
Precision Neuroscience, Corp.
319 N Bernardo Ave., Suite 157
Mountain View,  CA  94043
Correspondent Contact Jayme Strauss
Regulation Number882.1310
Classification Product Code
GYC  
Date Received09/03/2024
Decision Date 03/30/2025
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
-
-