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 K191301
Device Name Ceribell Pocket EEG Device
Applicant
Ceribell, Inc.
2483 Old Middlefield Way, Suite 120
Mountain View,  CA  94043
Applicant Contact Josef Parvizi
Correspondent
Ceribell, Inc.
2483 Old Middlefield Way, Suite 120
Mountain View,  CA  94043
Correspondent Contact Josef Parvizi
Regulation Number882.1400
Classification Product Code
OMB  
Subsequent Product Codes
GWQ   OMC  
Date Received05/14/2019
Decision Date 09/11/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-