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 Stimulator, Photic, Evoked Response
510(k) Number K211643
Device Name Vision Monitor - MonpackONE
Applicant
Metrovision
4 Rue Des Platanes
Perenchies,  FR 59840
Applicant Contact Jacques Charlier
Correspondent
Metrovision
4 Rue Des Platanes
Perenchies,  FR 59840
Correspondent Contact Jacques Charlier
Regulation Number882.1890
Classification Product Code
GWE  
Subsequent Product Code
HLT  
Date Received05/27/2021
Decision Date 07/26/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-