• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)

  • 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 strabismus detection device
De Novo Number DEN130051
Device Name PEDIATRIC VISION SCANNER
Requester
rebiscan, inc.
30 mount auburn street, ste b
cambridge,  MA  02138
Contact justin g shaka
Regulation Number886.1342
Classification Product Code
PMW  
Date Received12/13/2013
Decision Date 06/08/2016
Decision granted (DENG)
Classification Advisory Committee Ophthalmic
Review Advisory Committee Ophthalmic
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
-
-