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 Automatic Event Detection Software For Full-Montage Electroencephalograph
510(k) Number K252160
Device Name Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))
Applicant
Persyst Development, LLC
420 Stevens Ave., Suite 210
Solana Beach,  CA  92075
Applicant Contact Dari Darabbeigi
Correspondent
Persyst Development, LLC
420 Stevens Ave., Suite 210
Solana Beach,  CA  92075
Correspondent Contact Dari Darabbeigi
Regulation Number882.1400
Classification Product Code
OMB  
Subsequent Product Codes
OLT   OLX   OMA  
Date Received07/10/2025
Decision Date 10/31/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-