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 Media, Electroconductive
510(k) Number K212325
Device Name EEG-acp
Applicant
SOMNOmedics GmbH
Am Sonnenstuhl 63
Randersacker,  DE 97236
Applicant Contact Sabrina Forster
Correspondent
SOMNOmedics GmbH
Am Sonnenstuhl 63
Randersacker,  DE 97236
Correspondent Contact Timo Gehring
Regulation Number882.1275
Classification Product Code
GYB  
Date Received07/26/2021
Decision Date 06/15/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-