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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name camera, ophthalmic, ac-powered
510(K) Number K120982
Model MIIS HORUS SCOPE DEC 100
Device Name DIGITAL EYE-FUNDUS CAMERA
Applicant
MEDIMAGING INTEGRATED SOLUTIONS, INC. (MIIS)
1f, no. 7, r&d rd ii
hsunchu science park
hsinchu, 
Contact chih-lu hsu
Regulation Number886.1120
Classification Product Code
HKI  
Date Received04/02/2012
Decision Date 09/28/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Ophthalmic
Review Advisory Committee Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-