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 Reduced- Montage Standard Electroencephalograph
510(k) Number K192549
Device Name Byteflies Kit
Applicant
Byteflies NV
Borsbeeksebrug 22 Floor 6
Antwerp,  BE B-2600
Applicant Contact Benjamin Vandendriessche
Correspondent
Medicsense USA
Borsbeeksebrug 22, 6th Floor
Berchem
Antwerpen,  BE 2600
Correspondent Contact Benjamin Vandendriessche
Regulation Number882.1400
Classification Product Code
OMC  
Date Received09/17/2019
Decision Date 06/22/2020
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
-
-