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 Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety
510(k) Number K182311
Device Name Cervella
Applicant
Innovative Neurological Devices, LLC
13295 Illinois St., Suite 312
Carmel,  IN  46032
Applicant Contact Bart Waclawik
Correspondent
Innovative Neurological Devices, LLC
13295 Illinois St., Suite 312
Carmel,  IN  46032
Correspondent Contact Bart Waclawik
Regulation Number882.5800
Classification Product Code
QJQ  
Date Received08/24/2018
Decision Date 03/07/2019
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
-
-