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 Full-Montage Standard Electroencephalograph
510(k) Number K233403
Device Name Flexset System
Applicant
Zeto, Inc.
4917 Waters Edge Dr. Suite #221
Raleigh,  NC  27606
Applicant Contact Aswin Gunasekar
Correspondent
Medical Device Academy, Inc.
345
Lincoln Hill Rd.
Shrewsbury,  VT  05738
Correspondent Contact Mary Vater
Regulation Number882.1400
Classification Product Code
GWQ  
Subsequent Product Code
GXY  
Date Received10/04/2023
Decision Date 04/30/2024
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
-
-