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 Ophthalmoscope, Laser, Scanning
510(k) Number K111988
Device Name EASYSCAN MODEL 1.2
Applicant
I-Optics BV
220 River Rd.
Claremont,  NH  03743
Applicant Contact WILLIAM GREENROSE
Correspondent
I-Optics BV
220 River Rd.
Claremont,  NH  03743
Correspondent Contact WILLIAM GREENROSE
Regulation Number886.1570
Classification Product Code
MYC  
Date Received07/13/2011
Decision Date 10/28/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-