• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back To Search Results
Device Classification Name infrared hematoma detector
510(k) Number K120949
Device Name INFRASCANNER
Original Applicant
INFRASCAN, INC.
1835 market st., 29th floor
philadelphia,  PA  19103
Original Contact steven b datlof, m.d., j.d.
Regulation Number882.1935
Classification Product Code
OPT  
Date Received03/30/2012
Decision Date 01/11/2013
Decision substantially equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-